United Therapeutics

Date:

November 28, 2011

Title:

Compliance Auditor

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Silver Spring, MD

Experience Required:

A minimum of 4-6 years of auditing experience

Education Level:

Requires a bachelors degree in a science or engineering related field. Advanced degree preferred.

Role Purpose/Position Overview

The Quality Auditor will ensure that appropriate quality systems are in place for UT sites and the management of suppliers, including the qualification (auditing) of suppliers, implementation of Quality Agreements, support during regulatory inspections and quality improvement initiatives. The role will also be responsible for communicating with other UT departments in order to ensure Quality Assurance support for activities at suppliers and to identify, mitigate and resolve compliance and quality issues that may affect UT activities.

Key Accountabilities/Responsibilities

• Manage GMP audit program of CMOs and Suppliers, as well as potential CMOs/Suppliers, to assure compliance with UT standards and current Good Manufacturing Practice regulations and to assure adherence with specific IND/NDA/MAA commitments.
• Conduct external audits of CMOs (drug product), excipient manufacturers, container/closure manufacturers, contract packagers, analytical laboratories, and label printers.
• Conduct internal audits of UT systems including but not limited to: manufacturing centers, UT global sites, analytical data, technical reports, development reports, mock pre-approval inspections, computer systems and UT Quality Systems.
• Create detailed audit plans, write detailed reports of complex subjects, evaluate responses and corrective action plans, follow up on outstanding issues, and track on-going compliance with cGMPs.
• Deal effectively and diplomatically with CMOs, Suppliers and other UT departments. Coordinate audit activities with other team members when applicable.
•  Participate in the investigation of quality issues related to product failures, contractor complaints, customer complaints, or as directed by QA Management.
• Review and evaluate UT procedures and policies to assure consistency with pertinent government regulations and guidelines.
• Maintain expert knowledge of regulations, company procedures, auditing, and quality principles.
• Perform other quality or compliance related duties as assigned.

Requirements

• Bachelors degree in a science or engineering related field.  Advanced degree preferred.
• ASQ CQA or ISO lead auditor certification desirable but not required.
• A minimum of 4-6 years of experience auditing and/or managing suppliers in an FDA medical device/pharmaceutical regulated industry is required.
• Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside regulatory affairs, including upper management, external government personnel, and clinical  investigators and site personnel.
• Requires strong computer skills, Microsoft Office Applications (Access, Excel, Power Point and Word).
• Up to 50 % travel required to manage GMP activities and conduct site and vendor compliance audits.  Some international travel required.
• Working knowledge of GMP regulations and guidelines, both US and international. 
• Detail oriented and committed to seeing tasks through to completion. 
• Experience and comfort in working both independently and as part of a multifunctional team. 
• Proven organizational skills and strong ability to prioritize workload.  
• Commitment and ability to handle high workloads, stressful situations, and deadlines.
• Must be able to travel without restriction.
• Must be able to lift and carry training materials as needed. 
• Must be able to lift and carry up to 35 pounds throughout the day and on a regular basis.
• Will be exposed to a variety of environments on a daily basis.
• Office-based environment on non-travel days, sitting for long periods of time working with computer and telephone. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 05, 2012

Title:

Corporate Real Estate Administrative Assistant

Job Type:

Full-Time Position

Job Category:

Real Estate/Facilities

Location:

Silver Spring, MD

Experience Required:

2-3 years work experience.

Education Level:

Bachelor's Degree required.

Role Purpose/Position Overview

The Corporate Real Estate Administrative Assistant will assist the Real Estate/Facilities department in managing global Construction, Facilities and Real Estate matters.

Key Accountabilities/Responsibilities

Administrative Coordination

• Provide assistance to Corp Real Estate staff requiring additional administrative support (i.e..prepare confidentiality agreements, send faxes, copying and scanning, etc.)
• Manage organization of departmental filing system (electronic and paper)
• Manage contract approval process
• Data entry required
• Coordinate Business meetings and related travel
• Prepare and submit expense reports
• Additional duties as assigned by your manager to achieve company goals

 Real Estate Project Coordination

• Attend and report on construction meetings; maintain minutes for specialty meetings as requested
• Execute special research projects and data analysis tasks
• Assists with analyzing problems, determining approach, compiling and analyzing data and preparing reports and recommendations
• Track project progress and budgets
• Compose all types of correspondence (written/oral communication) with contractors & various county, state and federal agencies
• Attend community association meetings, planning meetings and hearings
• Solicit, review and comment on vendor contracts for services
• Manage project files, contracts & correspondence
• Coordinate project schedules and contact sheets
• Liaison with key consultants in relation to planning, engineering, and construction staff
• Schedule appointments and meetings
• Other duties as assigned

Requirements

• Bachelor’s degree required
• 2-3 years work experience
• Interest in Real Estate Management highly preferred
• Prior project coordination experience preferred
• Must be able to communicate in English effectively with other individuals
• Must be proficient in Microsoft Office (Word, Excel, Project Manager, and PowerPoint). Microsoft Excel will be used on a regular basis
• Ability to conduct limited travel in local Metro area

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

November 23, 2011

Title:

Food & Recreation Manager

Job Type:

Full-Time Position

Job Category:

HR

Location:

Silver Spring, MD

Experience Required:

5-7 years relevant experience; at least 3+ years of experience managing others (specifically a contract workforce)

Education Level:

Bachelors Degree (a plus if in psychology, counseling, theology or related fields)

Role Purpose/Position Overview

  Food & Recreation operations:

• Operate Silver Spring campus food services in a way to enhance morale and Silver Spring employee cohesiveness;
• Oversees the daily operations of the Silver Spring office food service function.  Manages food & beverage production, purchasing, inventory control, food costing, safety and sanitation regulations (including alcohol awareness); 
• Trains and manages all contracted food service staff; Continually assess food service providers to ensure they seamlessly integrating with the Company’s culture and ensures staff is adding positively to employee morale;
• Manages recreation activities to include promoting usage, hosting events and maintenance of all recreation equipment and food and beverage areas;
• Works with Human Resources to identify opportunities to further drive up morale.

Key Accountabilities/Responsibilities

Accountable for managing the cost of contract employees as well as food, beverage and other supplies.

Interact with various vendors (food, supply, etc) and employees in various departments.

Manage third party vendors

Interact with various vendors (food, supply, etc) and employees in various departments.

Requirements

5-7 years relevant experience; at least 3+ years of experience managing others (specifically a contract workforce)

• Experience with food service operations is essential
• Background in event planning or project management a plus
• A professional demeanor with the ability to work under minimal supervision
• Education in counseling, psychology or therapy a plus
• Certifications in psychology, counseling, AA facilitation are a plus
• Familiarity of the Neelix character on Star Trek Voyager, and able to identify with and perform his type functions.
• Local Metro Area travel as needed

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

November 01, 2011

Title:

GMP Engineer II / III

Job Type:

Full-Time Position

Job Category:

Manufacturing

Location:

Silver Spring, MD

Experience Required:

3+ years working in cGMP environment

Education Level:

High School Diploma or GED (Bachelors of Science preferred)

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Troubleshoot complex, mechanical and automated equipment issues to ensure optimal functionality while adhering to cGMPs
• Assist in writing/completing equipment SOPs, change controls and deviations
• Support/schedule Fill/Finish and Biologics preventative maintenance activities as defined by specific equipment protocols
• Effectively communicate technical issues with equipment vendors and supporting departments during troubleshooting activities and maintenance/repair visits
• Ensure the continuous, uninterrupted availability and functionality of Fill/Finish and Biologics equipment required to support production campaigns
• Support ongoing validation efforts for Fill/Finish equipment and processes 

Requirements

• Some travel maybe required
• Not a requirement but strong candidate would be proficient in troubleshooting PLC issues using Simatic s7 and/or RSLogix 5000. 
• Proficient in all Microsoft Office applications

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

February 03, 2012

Title:

IT Project Manager - Part Time

Job Type:

Part-Time Position

Job Category:

IT

Location:

Silver Spring, MD

Experience Required:

Minimum 5-10 yrs project management or IT Mgmt. PMP Certification or equivalent preferred.

Education Level:

Bachelors Degree

Role Purpose/Position Overview

This position accomplishes project objectives by planning and evaluating project activities.

Key Accountabilities/Responsibilities

• Runs complex projects/programs from design and development to production.
• Defines requirements and plan project lifecycle deployment.
• Defines resources and schedule for project/program implementation.
• Create strategies for risk mitigation and contingency planning.
• Plans and schedule project deliverables, goals, milestones.
• Directs and oversees project engineering team and manages conflicts within group.
• Performs team assessments and evaluations.
• Efficiently identifies and solves project issues.
• Demonstrates leadership to define requirements for project risk.
• Develop Requests for Proposals (RFP) for external services.
• Designs and maintain technical and project documentation.
• Strong organizational, presentation, and customer service skills.

 And other duties as required. 

Requirements

• PMP (Project Management Professional) Certification or equivalent preferred.
• Minimum 5-10 years of project management or IT Management.
• Minimum 3 years experience coordinating and/supporting IT business processes.
• Experience with Microsoft Windows (XP, Vista, 7), Microsoft Windows Server, Infrastructure builds (datacenters, ISPs), Vendor Management
• Experience developing and tracking budgets, coaching, supervision, staffing, process improvement, planning
• 25% - 50% travel required (domestic and foreign). Several trips are required to service various offices, usually on very short notice.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

September 07, 2011

Title:

Intern-Corporate Real Estate Management & Development

Job Type:

Internship

Job Category:

Real Estate/Facilities

Location:

Silver Spring, MD

Experience Required:

Education Level:

Current College Student

Role Purpose/Position Overview

We have a corporate real estate portfolio that includes over 25 owned and/or leased properties within North America and Europe.  As a corporate real estate intern, you’ll be actively involved in numerous aspects relating to the portfolio, including lease administration, facilities management, tax analysis, construction and improvements, acquisition and disposition analysis, and administrative upkeep.  Several construction and renovation projects are scheduled to commence in coming months.

Key Accountabilities/Responsibilities

Duties will include:

• Analysis and duties relating to various aspects of the corporate real estate portfolio
• Written / oral communication with various county, state and federal agencies
• Creating spreadsheets (i.e. lease abstracts, lease compliance, real estate tax analysis)
• Assist with new research and development / office / developments
• General office work
• Written / oral communication with contractors, vendors, and consultants
• Perform internet research
• Learn various aspects of the corporate real estate, facilities management and construction industries
• Gain an understanding of how each aspect of the industry functions - financial, legal, construction, project management, leasing, etc
• Improve analytical, negotiating, written and management skills

Requirements

• Must be currently enrolled in college
• Office environment- must be able to sit for long periods of time while using the phone and computer extensivel

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 05, 2012

Title:

Maintenance Operator I/II

Job Type:

Full-Time Position

Job Category:

Engineering

Location:

Silver Spring, MD

Experience Required:

2-3 years experience maintenance work in manufacturing and/or scientific facility environment preferred

Education Level:

High school diploma or equivelant required

Role Purpose/Position Overview

This position has the responsibility to ensure proper operations and maintenance of all facility systems.  The main emphasis will be to provide mechanical repair support to/for the facilities and equipment in accordance with GLP and cGMP requirements where and when appropriate at the Silver Spring facilities.

Key Accountabilities/Responsibilities

• Perform duties as required by Work Order requests, controlling costs, ensuring quality of workmanship, safety, and completion of required documentation as assigned by supervisor.
• Perform Preventative Maintenance, log repairs on equipment and keep accurate records of work completed.  Update and enter new information to the Preventive Maintenance database.
• Responsible for minor renovation and construction on existing facilities as needed.
• Monitor the building alarm systems, ensuring proper functioning and record of actions.
• Provide “on-call” support responding to off-hour building alarms as needed.
• Identify critical spare parts and maintain proper inventory.
• Ensure buildings are maintained  clean and debris free environment.

Performance in this job function must be in compliance with safety, health, environmental, and governmental regulations, and in compliance with Unither SOP’s.

Requirements

• High school diploma or equivalent required.  Vocational education at minimum with focus on mechanical, plumbing, electrical and HVAC skills desirable.
• Two to three years experience maintenance work in a manufacturing and/or scientific facility environment preferred.
• Basic computer skills needed.
• Training in fire protection, OSHA safety, GLP, cGMP and internal safety procedures.  Skills in overall facility maintenance.  Able to operate and repair basic machines, pumps and motors.  Good interpersonal skills.  Basic documentation practices.
• Considerable time spent on feet. Individual must push, pull, climb, grasp, kneel, crouch, crawl, reach, handle, etc.  Individual must be capable of lifting a minimum of 50 lbs.                                                  
• Hazards: Include possible exposure to hazardous materials, chemicals

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

November 15, 2011

Title:

Manager, Office Administration

Job Type:

Full-Time Position

Job Category:

Administrative

Location:

Silver Spring, MD

Experience Required:

6 + relevant administrative experience; At least 4 years experience managing direct reports

Education Level:

HIgh School Diploma; 1-2 years of Secretarial/Business School

Role Purpose/Position Overview

The Manager of Office Administration manages office activities to achieve maximum expense control and ensure the office is run smoothly.

Key Accountabilities/Responsibilities

• Maintain inventory of office supplies and order supplies as needed. Plan ahead for supplies needed for upcoming events (e.g. name tags and binders for conferences, special paper for reports, etc.)
• Ensure that office equipment are maintained and operating properly
• Maintain clean, orderly, friendly, and professional office environment including ensuring all kitchens are sufficient supplied.
• Procure appropriate service agreements and maintain these (copiers, plant service, etc.)
• Coordinates shredding vendor schedule
• Manages required county transportation program
• Assists and coordinates inter office moves
• Manages mail distribution, fax distribution, conference room and meeting set-up, etc.
• Responsible for distribution of parking permits and managing building parking spots
• Coordinates the ordering of business cards and letterhead. 
• Establish individual UPS and Intercall accounts if necessary
• Back up for the Receptionist
• Liaison with Bright Horizon for Daycare needs
• All other duties as assigned

Requirements

• High School Diploma
• 1-2 years of secretarial/business school
• 6+ years relevant administrative experience
• At least 4+ years of experience managing multiple employees in a comparable sized environment
• Proficient in MS Word, Excel, Power Point
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Self Motivated, multi-tasked, strong organizational skills, excellent communications skills
• Ability to travel within Local Metro Area as needed

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 13, 2012

Title:

Manufacturing Associate I, Cell Culture

Job Type:

Full-Time Position

Job Category:

Manufacturing

Location:

Silver Spring, MD

Experience Required:

0-2 years

Education Level:

Bachelors degree required or related experience

Role Purpose/Position Overview

The Manufacturing Associate I, Cell Culture, will under supervision, perform manufacturing activities related to the production of biopharmaceutical products in a cGMP environment.

Key Accountabilities/Responsibilities

• Operation of bioprocess equipment under strict adherence to cGMP, OSHA and United Therapeutics policies and regulations
• Receive and handle production raw materials
• Maintain and prepare production documentation
• Assist with technical issues and problems
• Scale-up and basic trouble-
• shooting, assist with technical issues
• Monitor and audit work processes to ensure compliance and completion of targets 
• Maintain personal cGMP training to ensure compliance
• Other duties as assigned

Requirements

• Ability to work shifts to cover a 24/7 operation
• Ability to lift and carry as much as 40lbs
• Demonstrate ability to work effectively in a team
• Strong documentation practices
• Strong verbal and written skills
• Other duties as assigned
• Occasional travel may be required

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 13, 2011

Title:

Part- Time Training Coordinator

Job Type:

Part-Time Position

Job Category:

HR

Location:

Silver Spring, MD

Experience Required:

Minimum 1-2 years of experience as part of a training / learning and development department.

Education Level:

BA in a relevant discipline (Learning & Development, Organizational Development, Communications, Adult Learning) is required.

Role Purpose/Position Overview

• Promote and advance a learning culture within the organization.
• Support LEAD Training Department operations.
• Manage Corporate LMS system.
• Aid in learning content development and conduct training as appropriate 

Key Accountabilities/Responsibilities

• Act as the LMS administrator: upload content, create and maintain the training schedule, manage all communications regarding learning events / needs, manage evaluations, produce reports, identify trends, etc.
• Help create and maintain a communication strategy to market learning events, the department, and key learning information.
• Review training materials prepared by instructors, such as outlines, text, and handouts.
• Coordinate the production of training materials.
• Manage course evaluations in order to continually evaluate training effectiveness.
• Acts as a support fielding questions and issues from staff related to the business and / or systems.
• Maintain training materials and make recommended improvements as necessary
• Handles related tasks as assigned.

Requirements

• Proficient in MS Word and PowerPoint.
• 1-2 years experience working as an LMS administrator: creating learning events, managing enrollments, uploading content, etc.
• Experience with e-learning authoring tools such as Articulate, Captivate, Lectora, Moodle, etc.
• Experience with SharePoint a plus.
• Excellent oral and written communication skills
• Strong attention to detail and organization.
• Ability to handle multiple projects and priorities in a professional and timely manner.
• Consistency with processes and daily tasks
• Self-starter and proactive approach in resolving issues.
• Ability to read, analyze and interpret general information and data
• Ability to interact with all levels of personnel.
• Troubleshooting skills
• Ability to effectively present information in a clear manner, demonstrate procedures and respond to questions
• 20% of travel to UT Subsidiaries is required in this position.
• Monitor training costs to ensure budget is not exceeded, and prepare budget reports to justify expenditures.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 30, 2011

Title:

QA Specialist II, Training

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Silver Spring, MD

Experience Required:

3 years of relevant pharmaceutical industry experience

Education Level:

Bachelor’s degree

Role Purpose/Position Overview

The QA Specialist will be responsible for the administration of the ComplianceWire Learning Management System (LMS) at the United Therapeutics Silver Spring facility; provide training and training support at the Silver Spring site.

Key Accountabilities/Responsibilities

• Supervise usage and administration of LMS (Site Administrator).
• Train site users and administrators on LMS.
• Input external training activities and training related information into the LMS.
• Conduct/coordinate New Hire GMP training.
• Provide training support.
• Ensure training consistency across UT sites.
• Coordinate and support cross-departmental use of the LMS (e.g., Corporate Training & Development, EHS, Sales Compliance, Global Clinical Quality, Training & Standards, etc.).
• Schedule and coordinates training activities.
• Assist in the performance of Quality related training.
• Assist in the tracking of training events for all contractors, consultants, and temps based at Silver Spring.
• Maintain training records.
• Collects training documentation, checks for accuracy & completeness, and coordinates for corrections when necessary.
• All other duties as assigned.

Requirements

• Bachelor’s degree, preferably in a scientific related field.
• At least 3 years of relevant pharmaceutical industry experience with an in-depth understanding of GMPs and at least three years of training experience.
• Utilize MS office to create various documents, spreadsheets, charts, and graphs.
• Travel to the RTP site may be required. Not more than 10%.
• Strong analytical and communication skills (multitasking and prioritizing), strong attention to detail.
• Usage and administration of LMS (Site Administrator).

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 04, 2012

Title:

Raw Materials Analyst I

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Silver Spring, MD

Experience Required:

Minimum of 2 years related experience

Education Level:

Bachelors degree in a scientific discipline

Role Purpose/Position Overview

This position is responsible for sampling, testing, releasing and maintaining raw material inventory, in process materials and finished formulations.  Position will assist in the development of the Raw Materials program by developing and writing raw material specifications.

Key Accountabilities/Responsibilities

Conducts routine and non-routine sampling of raw materials, in process, and finished formulations according to SOPs. Revises and updates standard operating procedures and raw material specifications as needed.  May perform special projects on analytical and instrument problem solving.  Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. 

Requirements

• Bachelor’s degree, preferably in a scientific related field.
• Travel required between warehouse and Silver Spring site
• Knowledge of chemical hazards and basic scientific principles
• Must be able to lift up to 75 lbs on a weekly basis 
• Basic computer skills

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 13, 2011

Title:

Sr. Accounts Payable Specialist

Job Type:

Full-Time Position

Job Category:

Finance Accounting

Location:

Silver Spring, MD

Experience Required:

3+ yearsf full cycle Accounts Payable experience required

Education Level:

High school diploma

Role Purpose/Position Overview

Processing Accounts Payable invoices in accordance with company SOP’s.

Key Accountabilities/Responsibilities

• Process all expenses with the proper GL account, Internal Order, Cost Center, and budget information. 
• Review employee expense entries in Concur.
• Process UTC and all subsidiary wires in Wachovia for mid-month, end of month and weekly OOC Payments.
• AP monthly reconciliations for all companies with the exception of Unither Telmed. Ltd. and Unither.com.
• Ensure all recurring payables and approved invoices received via the AP Mailbox are printed and entered for each cycle.
• Ensure all unapproved invoices received via the AP Mailbox are printed and routed out for approval.
• Ensure invoices are appropriately approved.
• Enter completed invoices into SAP accounting system.
• Ensure each vendor has a W9 on file.
• Resolve vendor related issues promptly and professionally.
• Meet A/P deadlines.
• Filing and maintaining AP vendor files in accordance to departmental policy.
• Assist Finance Department in all areas as needed.
• Other duties as assigned

Requirements

• Microsoft Excel efficiency preferred (Intermediate level)
• Experience with a general ledger accounting system required
• Very detail oriented
• Handle multiple tasks concurrently
• Excellent oral and written communications skills
• Strong interpersonal and organization skills
• Strong problem solving skills
• Able to work independently
• Able to follow instructions and guidelines
• Responsible for accurately coding invoices using GL chart of accounts.
• Responsible for utilizing company budget sheets to properly code invoices.
• Responsible for adhering to current company policies.
• Responsible for complying with changes and updates to policies, procedures, and company SOP’s.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

February 02, 2012

Title:

Systems Administrator

Job Type:

Full-Time Position

Job Category:

IT

Location:

Silver Spring, MD

Experience Required:

2+ years Microsoft Windows (XP, Vista, 7), 1+ years of Vendor management, Invoice and budget tracking, 1+ years Microsoft Windows Server (2003, 2008, 2008R2) including Active Directory experience

Education Level:

Bachelor of Science Degree in Information Technology, Systems Administration, or related IT field

Role Purpose/Position Overview

The Systems Administrator will support related infrastructure services on a regional and global perspective, will assist with development, design, and technology integration efforts for various projects. Responsibilities will include direct support to Help Desk team as needed, developing and maintaining appropriate documentation of the infrastructure and services provided.

Key Accountabilities/Responsibilities

• Maintain existing IT services
• Implement new services that fit within our current and forward thinking business model
• Compliance with security & regulatory standards
• Resourceful in implementation and deployment strategies of best practices and policies
• Liaise with vendors as required
• Work will be approximately 50% Project based and 50% Break/Fix

And other duties as required

Requirements

• MCSE and MCITP or equivalent industry &/or relevant Windows infrastructure experience desired
• CCNA or equivalent industry &/or business networking experience desired 
• 2+ years Microsoft Windows (XP, Vista, 7)
• 1+ years of Vendor management, Invoice and budget tracking
• 1+ years Microsoft Windows Server (2003, 2008, 2008R2) including Active Directory experience
• 1+ years Microsoft Exchange (2007, 2010)
• 1+ years VMware (ESXi, ESX, vSphere 4.x, 5.0)
• 1+ years Terminal Services and Citrix
• 1+ years Symantec Backup Exec or Net Backup
• Deep familiarity with a vast number of applications and technologies such as: Office 2010, Video conferencing, VoIP, wireless technologies (infrastructure AD authentication), Server hardware, Storage Area Networks, iSCSI devices, etc. 
• 0% - 25% travel required (domestic and foreign). Sometimes at a moment’s notice. Several trips are required to service various offices, usually on very short notice.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

November 15, 2011

Title:

Validation Tech

Job Type:

Full-Time Position

Job Category:

Manufacturing

Location:

Silver Spring, MD

Experience Required:

Minimum of 2 years pharmaceutical validation experience

Education Level:

High School Diploma Required (BS preferred)

Role Purpose/Position Overview

Under supervision, perform equipment and process qualification activities related to the production of bulk and finished pharmaceutical products in a cGMP environment. 

Key Accountabilities/Responsibilities

• Prepare IQ/OQ/PQ protocols, and Summary Reports as directed by company procedures, policies and industry standards.
• Schedule and execute qualification, re-qualification and change control activities.
• Perform process mapping and continuous improvement activities.
• Assist Manufacturing in product investigations and equipment troubleshooting.
• Support domestic and international regulatory agency inspections.
• Other duties as assigned.

Requirements

• High school diploma required (BD preferred)
• Minimum of 2 years pharmaceutical validation experience.
• Some travel may be required.
• Responsible for vendor interactions.
• Well versed in Microsoft Office (Word, Excel, PowerPoint, Project).
• Good communication skills.
• Also requires analytical problem-solving abilities.
• Office environment - must be able to sit for long periods of time while using the computer and phone extensively.
• Must be able to lift up to 35 pounds (boxes of paper files).
• May involve occasional heavy lifting.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 30, 2012

Title:

Customer Service and Reimbursement Associate

Job Type:

Full-Time Position

Job Category:

Customer Service

Location:

Satellite Beach, FL

Experience Required:

3 or more years

Education Level:

High School Diploma or Higher

Role Purpose/Position Overview

The United Therapeutics Customer Service and Reimbursement Associate will provide Customer Support and Reimbursement Services to Patients, Physicians, Specialty Pharmacy Partners, Payors and other UT clients, including internal departments.

Key Accountabilities/Responsibilities

The CSRA will demonstrate a strong work-ethic and commitment to providing exceptional support and services to all key stakeholders.

 Responsibilities include but are not limited to:

• Accept in-coming and conduct out-going communications related to Customer Service and Reimbursement Services
• Triage inquiries appropriately
• Conduct Communications Management including accurate data collection and documentation utilizing company software and best practices
• Adhere to Call Center Standards and established metrics
• Facilitate Customer Concern/ Issue Resolutions
• Escalate Issues as per established escalation protocols  
• Conduct timely and thorough Follow-up
• Provide general information and education services regarding UT products and services to clients, participants, clinicians, pharmacists and physicians and triage questions as necessary
• Work collaboratively with other associates/management to ensure best business practices are followed and shared
• Provide general insurance and reimbursement research assistance.
• Assist patients with gaining access to UT Patient Assistance Programs
• Participate in company approved on-going continuing education programs
• All other duties as required

Requirements

Previous 3+ years in a Customer Service/Support Environment, preferably healthcare related.

• Bi-Lingual Skills Preferred
• Proficiency with MS Office Suite and internet applications
• Essential Telephone and Electronic Communication Skills
• Demonstrated ability to work as a team member with a focus on exceeding customer/client expectations
• Ability to handle challenges in a professional manner
• Self-motivated and able to demonstrate initiative to work independently
• Strong interpersonal communication, time-management, organization and relationship building skills
• Ability to work flexible schedule if necessary 
• Must be able to sit for long periods while using the computer and phone extensively

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 05, 2012

Title:

Associate Director , Decision Support Analytics & Research

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Research Triangle Park, NC

Experience Required:

Minimum of 5-7 years of biopharmaceutical commercial analytics, market research, decision support analytics experience

Education Level:

BA / BS required, MBA or higher level Masters preferred.

Role Purpose/Position Overview

The Associate Director of Decision Support Analytics & Research will have full accountability for all aspects of a decision support analytics and market research primarily for brands currently marketed (and some pipeline products) by United Therapeutics. This includes but not limited to internal client interface with marketing management, sales management, department heads, field sales, legal, compliance, etc. Core responsibilities include data processing, analysis, reporting, market research, competitive intelligence, forecasting, decision analysis support for UT’s in-market brands.   

The Associate Director of Decision Support Analytics & Research will partner with UT Commercial organization and any other relevant UT functions with relevant data to aid and support decision making on strategies and tactics.  Provide and help build solid infrastructure for evidence-based decision making within UT.

Key Accountabilities/Responsibilities

• Aggregate, process, analyze, and report all commercial data (both activity level data as well as sales performance data) required by sales and marketing to maximize business effectiveness.
• Work with outside suppliers and partners to aid with data integration, data analysis, and data reporting.
• Work closely with commercial management to ensure their market research needs are being fulfilled.
• Manage internal / external resources to conduct meaningful market research to support UT’s brands.
• Work with market research vendors to ensure studies are being planned and executed according to specifications provided by management.
• Comfort with forecast model development and financial analyses, for support in decision making processes.
• Work with legal and strategic operations to ensure their data needs from compliance and reporting standpoint are being fulfilled.
• Assist with executive management data requests / report generation on an as needed basis. 

Requirements

• BA / BS required, MBA or higher level Masters preferred.
• Minimum of 5-7 years of biopharmaceutical commercial analytics, market research, decision support analytics experience.
• Experience in SalesForce.com / SAS / relational database background required.
• 2-3 years consulting experience.
• Self-motivated individual, who is able to work independently, is flexible and able to prioritize business critical activities required.
• Comfortable in a fast-paced environment.
• Strong organization, critical thinking, analytical, communication and presentation skills required.
• Attention to detail and appreciation of deadlines is essential.
• Excellent written and verbal communication skills required.
• 25% travel.
• MS office, Access, SAS, Salesforce.com

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 08, 2011

Title:

Associate Manager, Speaker Programs

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Research Triangle Park, NC

Experience Required:

Minimum 3 years in pharmaceutical / biotech speaker program planning and implementation and / or sales

Education Level:

Bachelor's Degree

Role Purpose/Position Overview

The Associate Manager of Speaker Programs will lead the planning and execution of promotional speaker programs for United Therapeutics.

Key Accountabilities/Responsibilities

• Develop annual plan for speaker programs including objectives and metrics.
• Evolve speaker programs in content and format to better meet customer needs.
• Manage logistical aspects of speaker programs including vendor management, speaker contracting, and budget management.
• Track and share metrics routinely with key stakeholders (Sales Management, Brand Teams, Medical Affairs, Compliance).
• Partner with the sales force, brand teams, and Medical Affairs to understand their needs and ensure optimal implementation of programs.
• Partner with Medical Affairs in speaker identification and evaluation.
• Lead speaker training including annual live speaker training event.
• Integrate speaker program activities with Collaborative Outreach and Expertise (CORE) program.
• Support compliance with speaker program guidelines.

Requirements

• Bachelor’s degree.
• Minimum 3 years in pharmaceutical / biotech speaker program planning and implementation and / or sales.
• 20-40% for speaker program participation, field visits, sales meetings, congresses etc.
• Understand brand strategy and translate that strategy into effective speaker programs.  Coordinate on Key Opinion Leader planning. 
• Detail-oriented.
• Excellent communication and interpersonal skills.
• Good organizational skills.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

November 22, 2011

Title:

Documentum Administrator

Job Type:

Full-Time Position

Job Category:

IT

Location:

Research Triangle Park, NC

Experience Required:

2-5 years direct experience implementing and supporting validated systems in GCP/GMP applications.

Education Level:

Requires a bachelor’s degree, preferably in a science/technical field

Role Purpose/Position Overview

The Documentum Administrator position involves providing Administrative and technical assistance in identifying, evaluating and developing systems and procedures that are cost-effective and meet user requirements. The person is involved directly supporting the development, installation, configuration and customization of Documentum components. Configures system settings and options; plans and executes unit integration and acceptance testing; and creates specifications for systems to meet business requirements.

Daily responsibilities will include the development of customizations, installation, debugging and support of Documentum based applications software. May participate in cross-functional linked teams to address business or systems issues or requirements.

Key Accountabilities/Responsibilities

• Work within company framework to implement and maintain validated documentum environments for GCP/GMP systems (EDMS, ECTD publishing) in accordance with 21CFR 11.
  • Create/update/execute required documentation (eg, URS, FRS, IQ/OQ/PQ Plans, Scripts, Reports).
  • Responsible for monitoring software upgrade requirements and ensuring compliance.
  • Assist in the development of user and system administration documentation.
  • Assist in Documentum migrations.
  • Should be knowledgeable of Documentum performance issues, optimization, as well as performance troubleshooting and tuning techniques.
• Provide end-user support.
• Provide technical consulting support on project or system issues.
• Supports and publishes regulatory submissions.
• Identify technical issues with source files and published output

Requirements

• Requires a bachelor’s degree, preferably in a science/technical field.
• 2-5 years direct experience implementing and supporting validated systems in GCP/GMP applications.
• Working knowledge of electronic document management (Documentum) and submission software (i.e., InSight Publisher). Working knowledge of word processing, spreadsheet, and email software.
• Occasional travel required to conduct regulatory activities and to attend educational meetings (e.g., IT trainings, advertising, drug safety, etc.).
• Detail oriented and committed to seeing tasks through to completion. 
• Ability to work independently and as part of a multifunctional team. 
• Proven organizational skills and strong ability to prioritize workload.  
• Ability to handle high workloads, stressful situations, and deadlines.
• Ability to work overtime as needed. 
• Ticketing System (Servicedesk, Service Now), Office 2003-2010, MS Outlook & Other email clients, Windows Server 2000-2008, FTP & other file-transfer services, Web services, RDC/ThinApps and Print servers, AD & MS Exchange administration.
• Operating Systems: XP, Windows 7, MAC OS/x.
• Excellent communication and interpersonal skills.
• Ability to manage multiple tasks with multiple end dates simultaneously.
• Capability of explaining simple procedures verbally or in written form; required excellent phone and time management skills.
• Experience with cellular, videoconferencing, VoIP and PBX technologies.
• General knowledge of computer equipment such as PCs, servers, and printers; information technology principles and procedures, including record keeping, maintenance and operation; modern office procedure.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

September 07, 2011

Title:

GCP Compliance Associate

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Research Triangle Park, NC

Experience Required:

5 years of pharmaceutical industry experience

Education Level:

Bachelor’s degree in a science related field.

Role Purpose/Position Overview

This individual will assist in all aspects of clinical compliance and QA activities, including documentation review, internal process audits and external site and vendor audits and follow-up, providing guidance to clinical operations, data management and statistics, and drug safety, ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines, United Therapeutics SOPs, and study requirements.

Key Accountabilities/Responsibilities

• Assist in implementing and maintaining a comprehensive GCP compliant quality program.
• Plan and conduct external site and vendor audits according to UT SOPs.
• Assist in reviewing audit responses and evaluation adequacy of corrective actions/preventative actions (CAPAs).
• Assist with regulatory agency and other audits/inspections of RTP office, UTEL office, and clinical sites.
• Assist in identifying and developing standard operating procedures (SOPs) and systems needed to comply with regulatory requirements.
• Plan and conduct internal clinical process audits according to UT SOPs.
• Perform quality assurance reviews of protocols/amendments, clinical study reports and other study documentation as necessary.
• Perform document record review including, general study files, site specific study files, both clinical and pharmacological, etc.
• Perform trending analysis/metrics of audit findings and assist in providing summary reports to management of audit activities.
• Assist in the coordination and conduct of clinical/departmental training programs.

Requirements

• Bachelor’s degree in a science related field.
• At least five years or relevant pharmaceutical industry experience which includes at least two years of direct quality assurance or regulatory compliance experience. 
• Experience with clinical CAPAs, trending analysis, and/or pharmacovigilance audits preferred.
• Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, external government personnel, vendor personnel, clinical investigators and site personnel.
• Working knowledge of GCP/ICH regulations and guidelines.  Experience with international regulatory practices. 
• Detail oriented and commited to seeing tasks through to completion. 
• Experience and comfort in working both independently and as part of a multifunctional team. 
• Proven organizational skills and strong ability to prioritize workload. 
• Commitment and ability to handle high workloads, stressful situations, and deadlines.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 24, 2012

Title:

GMP Purchasing Manager

Job Type:

Full-Time Position

Job Category:

Finance Accounting

Location:

Research Triangle Park, NC

Experience Required:

Minimum of 15 years purchasing experience, with a minimum of 5 years in Pharmaceutical and Biotech discipline

Education Level:

Bachelor’s Degree in Business, Supply Chain Management, or in related field required.

Role Purpose/Position Overview

Lead purchasing efforts for all employees reporting under the COO/president with a concentration on the purchase of all GMP material.  Responsible for all contract negotiation of direct materials and oversight over all indirect materials.

Key Accountabilities/Responsibilities

• Responsible for price negotiation, identification and source selection as well as contract review for all GMP materials.
• Assist Sr. Director of Financial Management- RTP and Manager of Financial Business Systems RTP and Purchasing Specialist with migration of the existing PO system into best practices in SAP.
•  Assure that all direct materials are in compliance with approved vendor list supplied by the Compliance group.
• Negotiates purchase contracts with vendors, including follow-up, scheduling, and expediting deliveries. 
• Build and develop relationships with key suppliers and customers.  Manage vendor relationship and assist in building effective partnerships.
• Monitor Purchasing activities and measurements including the compilation of maintenance of organized purchasing records by assuring that purchase activities are fully documented. 
• Responsible for planning, developing and buying of GMP materials, supplies, and equipment in a timely and cost effective way; timely manner while maintaining appropriate quality standards and specifications. 
• Develops and implements purchasing strategies, policies, and procedures in conjunction with the Sr. Director of Finance.
• Oversight over all areas of purchasing for any areas falling under the org structure of COO/President.
•  Ongoing review of existing system to ensure that we are aligned with best practices.
• Assists other departments in reducing their supply/equipment costs.

Requirements

• Strong negotiating skills.
• Strong analytical and problem solving skills to including collecting and analyzing data resulting in fiscally responsible decisions.
• Detailed knowledge of efficient flow of a purchasing system and the necessary controls to be maintained.
• Ability to multi-task, strong organization skills and superior attention to detail.
• Knowledge of vendors and sources of supply with biotech suppliers, both US and Globally.
• Knowledge of GMP’s related to specifications, qualifications and material and vendor’s requirements in the pharmaceutical industry. Also knowledge of GMP & FDA legal related contract language writing.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

October 10, 2011

Title:

Manufacturing Automation Systems Engineer

Job Type:

Full-Time Position

Job Category:

Manufacturing

Location:

Research Triangle Park, NC

Experience Required:

5 years or more

Education Level:

Bachelor's degree in Information Technology, Chemical Engineering or Bio-Engineering

Role Purpose/Position Overview

The Manufacturing Automation Systems Engineer will provide key technical / automation support for various manufacturing and manufacturing support systems such as MES, ERP, PLCs, CDMS, PR, LIMS and chromatography systems in a regulated, validated environment.

Key Accountabilities/Responsibilities

• Perform trouble-shooting of challenging equipment / automation issues to improve manufacturing performance and maintenance of the automation systems in compliance with cGMPs
• Assure plant preventive maintenance, metrology, equipment cleaning, security, safety, industrial hygiene and environmental protection programs are functioning effectively and meet regulatory and outside agency compliance requirements
• Provide technical / administrative support for FDA compliant problem reporting system to include planned or unplanned deviation investigations, out of specification investigations, CAPAs, change control and customer complaint tracking
• Ensure the continuous, uninterrupted availability and functionality of computer systems and coordinate appropriate resources to respond to outages and emergencies
• Participate as required on various project teams as additional manufacturing automation systems are implemented.
• Support ongoing validation efforts for the manufacturing plant, equipment and processes

Requirements

Minimum of 5 years experience in the FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing support systems trouble shooting, ERP shop floor support, PEM and calibration systems support. 

• 5 years experience in support of MES, PLCs, CDMS, LIMS and PR systems is required
• Strong verbal, presentation and technical writing skills
• Must have superior database maintenance / development experience
• Must have computer hardware / software validation and change control experience
• Must be able to lift 50 pounds
• Some travel maybe required

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 12, 2011

Title:

Medical Information Scientist

Job Type:

Full-Time Position

Job Category:

Drug Safety

Location:

Research Triangle Park, NC

Experience Required:

4 year degree

Education Level:

Minimum of 8 years experience in pharmacovigilance within the USA, Europe and ROW.

Role Purpose/Position Overview

The Medical Information Scientist will provide medical information in response to internal and external queries related to United Therapeutics product(s). 

The Medical Information Scientist will also disseminate product related information including literature searches for internal use ~ providing expertise and support to MSL’s, Sales and Marketing, Drug Safety, Regulatory and Compliance, Strategic Operations, and other departments as required.

Key Accountabilities/Responsibilities

• Facilitate intake and triage of inquiries as related to UT marketed products and products in development. Answer inquiries from customers and ensure that these are handled in a competent and timely manner, and appropriate responses (written or verbal) are provided. Log inquiries into MIMS database and process in accordance with SOPs  
• Prepare scientifically balanced responses to unsolicited request for both labeled and off-label indications. Establish and maintain a standard answers database by obtaining internal review and approval.  Maintain and distribute globally as appropriate and necessary.
• Provide verbal and written clinical and technical responses to inquiries related to UT products (marketed and in development) from the health care community, patients, and internal customers.
• Provide support for product launches
• Stay abreast of emerging scientific literature and clinical trial data, translate the data in applicable knowledge and develop scientific materials for key internal and external audiences
• Participate in any Medical Information projects including development of new systems, processes and standard operating procedures.
• Participate in the congress strategy, including staffing the scientific booth, and collecting and reporting data and competitive intelligence
• Review scientific materials for clinical and scientific accuracy
• Provide support to the Medical Science Liaison team
• Monitor compendia for changes in product listing descriptions
• Assist in the development and maintenance of product dossiers  
• Partner and collaborate effectively with internal and external business partners and
• Provide support for the electronic library system; will include using QUOSA.
• Report adverse events and product complaints in a timely manner  to Drug Safety and/or Compliance according SOP and to maintain Regulatory compliance
• All other duties as assigned

Requirements

• A clinical degree (RPh, MS Pharmacist, PharmD, Registered Nurse, Nurse Practitioner).

• 1-3 years biotechnology or pharmaceutical medical information or related experience preferred.
• Excellent medical writing skills required. Writing test will be administered.
• Ability to manage multiple projects simultaneously and according to agreed upon time lines and budgets
• Awareness of regulations and guidelines related to Medical Information and Medical Affairs.
• Superb verbal and written communication skills.

• Proficient in Microsoft Word and Excel and have database experience. 
• Experience in abstracting database (Embase and PubMed) preferred
• Experience with literature searches and full-text document retrieval preferred.

• Positive attitude and service oriented
• Good organizational skills.
• Good people management - Must be able to meet needs of inquirers.
• Must be reliable.
• Good time management skills and ability to prioritize.
• Self motivated and willing to learn new skills.
• General office environment, working with computers, telephones and working closely with coworkers.
• Must be able to travel as necessary to support and attend congresses,  professional development, or other business needs. 5% travel.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

September 04, 2011

Title:

Medical Safety Scientist

Job Type:

Full-Time Position

Job Category:

Drug Safety

Location:

Research Triangle Park, NC

Experience Required:

Minimum of 8 years experience in pharmacovigilance within the USA, Europe and ROW.

Education Level:

MD, PharmD or MBBS

Role Purpose/Position Overview

This position reports to the United Therapeutics (UT) Head Global Drug Safety with full accountability for all aspects of safety data analysis in support of a quality pharmacovigilance system to ensure the appropriate risk assessment, risk evaluation and management of all UT licensed and investigational medicinal products in compliance with all relevant international and national legislation, regulations and guidelines.   

Provide medical safety input, advice and guidance for UT product development teams. Interact with QPPV as necessary to assure the QPPV is informed of relevant safety information.

To provide leadership of safety issues for assigned products and programs representing Global Drug Safety (GDS) group in all regions  

To work with the Head of Global Drug Safety and others at UT and the company’s vendors to ensure the continued development of appropriate departmental policies, procedures, and training materials.

Key Accountabilities/Responsibilities

• Understand all aspects of pharmacovigilance in its totality.
• Provide medical expertise and implement standards for review of clinical trial and post-authorization adverse experience reports for expectedness, accuracy, quality and clinical importance, relationship to the suspect product as well as severity and seriousness; be able to provide reports for submission to regulatory authorities according to international regulatory requirements and Company objectives and timelines.
• Provide medical advice and support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles and other documents. This will involve training of other UT employees and investigators in safety and pharmacovigilance.
• Review data that might suggest a drug safety signal such as listings of adverse reactions, post-marketing studies (published or unpublished), pharmacoepidemiological studies and meta-analyses. Advise on the investigation of such signals by liaising with all relevant business units within United Therapeutics and clinical experts and then making recommendations about optimising the risks and benefits for a product.
• Implement safety signal detection activities.
• Assist with the drafting and revision of departmental policies and procedures, and to help with the development of training materials in support of the company’s safety reporting and pharmacovigilance operations.
• Create and manage documents such as periodic safety update reports, clinical expert reports, clinical study reports, product labeling, risk management plans, literature review and product information, particularly if they relate to drug safety, to assure that quality is maintained and that benefit / risk information is accurate.
• Represent GDS and present material, as requested, at external meetings (e.g. with regulatory authorities, potential partners, clinical investigators etc) where issues of drug safety are discussed.
• Maintain up-to-date knowledge about safety by attending relevant professional society meetings and attending appropriate training courses to develop skills.

Requirements

• Minimum 8 years experience in pharmacovigilance within the USA, Europe and ROW.
• 5+ years’ experience in a biotech/pharma postmarketing environment with proficiency in Drug Safety process flow, Signal detection and associated technology platforms, Adverse Event reporting, Risk Management, Epidemiology, Signal detection and associated technology platforms, contribution to and management of complex PV deliverables (e.g., PSURs, RMPs Clinical Expert Reports).
• Extensive experience writing pharmaceutical regulatory or clinical research documents, including periodic safety reports and risk management plans, and SOPs. 
• Additional experience in Regulatory Affairs would be highly preferred.
• Proficient PC and database user.
• Working Knowledge of MedDRA, advance skills in ARGUS, ARISg and/or Clintrace.
• Knowledge of document management and analytical tools i.e. Please Review/WISDOM.
• 20% travel required.
• Extensive background in medical safety, case analysis and signal detection.
• Strong application and interpretation of FDA, European, sFDA,  Japanese and ICH regulations and guidelines.
• Understanding of all pharmacovigilance and regulatory reporting requirements for clinical investigational drug studies and post marketing surveillance.
• Detailed knowledge of evolving regulations, policies and procedures and industry performance related to compliance.                                     

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 13, 2012

Title:

Nonclinical Scientist

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Research Triangle Park, NC

Experience Required:

For advanced degree, at least 2 years of pharmaceutical experience

Education Level:

Advance degree strongly preferred (DVM, PhD, MS), OR BA/BS with extensive preclinical development experience (7-10 years)

Role Purpose/Position Overview

The Nonclinical Scientist will coordinate and manage the conduct of nonclinical studies to support the successful submission and approval of products by the FDA and international regulatory agencies. 

Key Accountabilities/Responsibilities

Nonclinical Activities:

• Serve as primary lead for execution of various preclinical experiments or investigations, including pharmacology, toxicology, safety pharmacology and nonclinical ADME to support various development programs at UT.
• Oversee selection of lab/testing facilities, budget and contract negotiation
• Review and edit proposals, protocols and reports
• Ensure other functional areas within UT provide necessary material and services to lab/testing facilities
• Review external consultant reports (eg., Toxicokinetics)
• Manage external vendors/consultants to meet UT goals and budgets
• Assist in writing preclinical sections of internal reports and regulatory documents INDs, CTDs, Investigator Brochure, annual reports, etc
• Assist in writing responses to regulatory agency nonclinical queries
• Serve as nonclinical expert on multiple UT project teams
• Assist as nonclinical expert at regulatory agency meetings
• Serve as primary lead on academic preclinical study requests – review and process proposals, and track study conduct and reports
• Assist as nonclinical expert for all UT therapeutic areas
• Assist internal project planning (developing nonclinical project timelines, budgets)
• Assist in writing, review and coordination of nonclinical publications of UT compounds

 Miscellaneous Activities:

• Assist in the evaluation of new products, in-license opportunities
• Maintain training – internal SOPs, GLPs, continuing education
• Provide scientific literature reviews on preclinical areas of interest
• All other duties as assigned to meet company goals

Requirements

• Advance degree strongly preferred (DVM, PhD, MS), OR BA/BS with extensive preclinical development experience (7-10 years).
• For advanced degree, at least 2 years pharmaceutical company or CRO experience in nonclinical development or lab-based research.
• Formal toxicology training and industry experience preferred.
• Knowledge or experience with management or conduct of nonclinical studies at CROs to support drug development.
• Experience with nonclinical development of biologics (antibodies, proteins, cell therapy) is a plus.
• Applied knowledge of pharmocokinetics principles and applications is a plus.
• 15% Travel (As needed)
• Strong communication (oral and written) and analytical skills.
• Strong understanding of current GLPs (some familiarity with GCPs).
• Ability to work effectively in both independent and team environments.
• Demonstrated ability to work on multiple projects and activities.
• Strong decision-making, judgment and problem-solving skills.
• Strong work ethic and ability to focus on goals and drive tasks to completion within stated timelines

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 16, 2012

Title:

Product Manager

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Research Triangle Park, NC

Experience Required:

Minimum of 3 years biopharmaceutical sales and marketing experience.

Education Level:

Bachelors Degree required, MBA preferred

Role Purpose/Position Overview

The Product Manager (PM) will be responsible for driving brand strategy and tactics for Oral Treprostinil.

Key Accountabilities/Responsibilities

Market Planning

• The PM will be responsible for leading market research initiatives, forecasting, and development of annual budgets.  The PM will develop annual marketing plans and quarterly plans of action in collaboration with the field sales group and the director of marketing.  Will serve as the primary day to day manager for range of promotional and analytical marketing activities.
• The PM will manage the primary and secondary market research projects including qualitative and quantitative projects.

Material and Program Development

• The PM will be responsible for managing marketing initiatives for products including field promotional materials, patient education, professional programs and advertising.  This includes interface with advertising and medical communication agencies and frequent contact with the field sales organizations and assessment of their needs.   The PM will be responsible for shepherding new materials through the concept, development, cross-functional review, production and dissemination of new marketing collateral.
• The PM will manage day to day operations of 2-4 major ongoing marketing projects based on skill set. 

Field Visits

• In order to maintain direct interface with our external customers to meet their needs, the PM will ride in the field, attend conventions, and/or meet with customers directly.  Assimilation of this feedback with that from other sources will allow the PM to better identify market opportunities and issues.

Requirements

• Bachelors Degree required, MBA preferred.
• Minimum of 3 years biopharmaceutical sales and marketing experience.  Over 5 years of product marketing experience, distributor nursing experience and/or PAH therapeutic area experience strongly preferred.
• 30-50% travel.
• Self-motivated individual, willing to work independently and prioritize tasks.
• Comfortable with fast-paced environment.
• Possess strong organizational skills.
• Ability to multi-task.
• Strong analytical, communication and presentation skills.
• Attention to detail and appreciation of deadlines is essential.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 13, 2012

Title:

QA Specialist III

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Research Triangle Park, NC

Experience Required:

5 – 7 years of relevant pharmaceutical

Education Level:

Bachelor's Degree

Role Purpose/Position Overview

QA Specialist III provides support to the overall Quality Assurance program at the site.  Ensures plant operations are within cGMP, local procedures, and corporate policies.

Key Accountabilities/Responsibilities

• Perform release of raw materials, printed components and devices.
• Conduct batch record review for clinical, commercial drug product and device batches manufactured on behalf of or at the RTP facility.
• Assist in management of third party manufacturing record review and approval.
• Assist in trending metrics for manufacturing and third party manufacturers.
• Manage approved labeling materials (label master and revisions).
• Maintain batch related documentation including but not limited to issuance and management of APRs, batch records, logbooks, specifications, and complaints.
• Review deviations and manages CAPA follow up for third party manufacturers
• Assist in implementing and maintaining. the quality systems programs for the RTP site including but not limited to deviation management, document control of batch records, internal audit responses relative to product assurance.
• Independently create, review, and revise standard operating procedures and specifications for the RTP manufacturing site.
• Compile Annual Product Review data.
• Monitor, and communicate KPIs for raw material and finished good release.
• Provide overall support to QA activities.
• Support initiatives to ensure a harmonized approach across the organization.
• Identify significant issues to management and provide possible solutions.
• Participate in local quality system related decisions.
• Improve quality system productivity.

Requirements

• Bachelor’s degree.
• 5 – 7 years of relevant pharmaceutical industry experience in a cGMP environment with 2 years of direct batch record review/product release experience.
• Working knowledge of US FDA, EU and JP, GMP regulations.
• Detail oriented, self motivated, highly organized and have the ability to prioritize work.
• Ability to work independently and as part of a multi-functional team, being able to handle high workloads, stressful situations and deadlines.
• Background in solid dose manufacturing or packaging operations in a GMP environment is strongly preferred but not required.
• Understanding of CFR and internal procedures to interpret guidelines in multiple areas in quality systems.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

August 16, 2011

Title:

Research Scientist/ Regenerative Medicine

Job Type:

Full-Time Position

Job Category:

Product Development

Location:

Research Triangle Park, NC

Experience Required:

5 Years

Education Level:

Advanced Degree required/PhD preferred

Role Purpose/Position Overview

The Research Scientist for Regenerative Medicine will coordinate multiple regenerative medicine and cell therapy product development programs, including working with multidisciplinary teams on  non-clinical, clinical and manufacturing scale-up activities. This role will also help develop efficient processes for getting Regenerative Medicine product candidates through clinical development, ensuring regulatory compliance and efficient tracking into GMP (Good Manufacturing Practices) and commercial production.  Responsibilities span proof of concept basic research through preclinical and clinical research and development, as well as development of scalable, robust regulatory-compliant and product oriented cell/organ techniques.

Key Accountabilities/Responsibilities

• Help manage working collaborations with leading academic and industrial partners in the RM and cell therapy fields as well as leading clinicians and researchers within therapeutic areas of interest
• Help team and senior management maintain up to date knowledge in key academic and industry science in cell therapy and regenerative medicine and ensure company efforts reflect “state of the art” of current research findings in the field
• Work with team and senior management to determine when research efforts need to brought in-house and refined to maintain progress toward clinical application of findings
• Participate in decisions on developing internal infrastructure, hiring key personnel, and moving programs from external collaborators into the internal program
• Help identify new RM/cell therapy opportunities
• Assist with other non-clinical efforts, particularly biologics, as needed
• Act as operational liaison between RM core teams and existing clinical operations, regulatory and CMC/analytical groups to ensure seamless flow from research to marketed products.
• Develop appropriate training and procedures to efficiently drive cell therapy and RM programs into “mainstream” R & D and commercial efforts at UT Assist with other clinical programs, particularly biologics, as needed
• Help draft publications (abstracts, posters, manuscripts)
• Lead Clinical Investigator Brochure generation and updates
• Participate in preparation of regulatory submissions – IND, NDA, sNDA
• Assist in the evaluation of new products, in-license opportunities, etc.
• Assist project planning (developing project timelines, budgets)
• Participate in interactions with Steering Committees, Advisory Committees, Data Monitoring Committees, and Publication Committees in conjunction with the Project Leader
• Maintain training – SOPs, GCPs, continuing education
• All other duties as required.

Requirements

• 4 + years of experience in Regenerative Medicine and/or cell therapy field
• Expertise in cell therapy and cell culture required
• Expertise in 3-D cell culture and/or ex-vivo organ culture a plus
• Expertise in cardiopulmonary physiology a plus
• Excellent oral, analytical and written communications skills, exceptional demonstrated laboratory skills in the appropriate disciplines, excellent teamwork and team building skills. Ability to speak and write in English.
• Up to 40 % Travel as needed

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 10, 2012

Title:

Senior Manager of Clinical Quality

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Research Triangle Park, NC

Experience Required:

Ten years in biopharmaceutical research & development or CRO

Education Level:

Bachelor’s degree; scientific related field preferred.

Role Purpose/Position Overview

The Manager of Clinical Quality will lead and manage department Inspection Readiness for Clinical departments and maintain metrics on department adherence to regulatory requirements and department standards to ensure department quality.

The Manager of Clinical Quality will also develop and oversee a Quality Management Plans (QMP) for clinical functions and conduct Quality Control Visits to determine compliance with SOPs, ICH/GCP, applicable regulations, and study protocol. The manager will provide feedback on findings with critical attention to addressing issues with solution-oriented proposals.

Key Accountabilities/Responsibilities

• Develop and manage a Clinical department Inspection Readiness Plan.
• Develop, implement and monitor adherence to clinical department QMPs including the quality oversight of vendors and contractors assigned to clinical oversight of studies.
• Define, develop, implement and continually improve quality control measures within the Monitoring Program, including a list of standard quality checks to be performed as part of the Performance Assessment Visits (PAVs) and Quality Control (QC) visits.
• Develop and maintain guidelines for the conduct of Performance Assessment Visits (PAVs) and Quality Control (QC) Monitoring Visits to assess study conduct and overall site performance.
• Collect and analyze qualitative and quantitative results from PAVs and QC visits and report results to management team.
• Conduct periodic QC monitoring visits with a sample of sites and monitors and liaise with management on project compliance concerns or trends.
• Interact with CRA Managers to determine a plan for PAVs for each monitor on a routine or as needed basis.
• Provide and support to CRA Managers in conducting PAVs according to plan.
• Develop a tracking system to ensure regular PAVs are done for all monitors.
• Communicate concerns or progress and resolution of issues resulting from PAVs and QC visits to appropriate clinical staff.
• Work with CRA Managers and Monitors to address concerns and resolve issues through on-site assessment and training when potential compliance issues are identified.
• Conduct QC assessments to verify selected study documents are complete and correct.
• Provide on-site training for monitoring staff as needed.
• Collaborate with Clinical Training and Standards in the development and presentation of continuing education sessions based on QC visit and PAV findings.
• Develop reports for management to highlight concerns and action plans.
• Collaborate with GCP Compliance/QA to identify trends from GCP Compliance/ QA site audits and make recommendations to management to improve overall findings.
• Identify need and assist with implementation of process and efficiency improvement.
• Support clinical team in preparing for external audits.
• Support clinical team by providing input into the generation of timely and appropriate audit responses.
• Provide staff support by answering questions or providing advice on ICH, GCP, SOPs, local regulations and guidelines.
• Maintain strong working knowledge of SOPs as well as ICH, GCP, local regulations and guidelines.
• All other duties as required.

Requirements

• Bachelor’s degree; scientific related field preferred.
• Ten years in biopharmaceutical research & development or CRO
• Eight years as a CRA and/or Clinical Manager in the biopharmaceutical industry preferred.
• Four years experience in a staff leadership role.
• Experience with developing SOPs and department processes.
• Experience with quality assurance audits preferred.
• Experience with training and mentoring clinical research staff.
• Computer software experience including Microsoft Office products and e-mail.  EDC and CTMS experience desirable.
• Minimum of 30% to various locations, as directed.
• Strong working knowledge of US FDA, EU and GCP and local regulations is required. 
• Detail oriented, self motivated, organized and have the ability to prioritize work.
• Ability to work independently and as part of a multi-functional team.
• Ability to handle high workloads, stressful situation and deadlines. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

October 17, 2011

Title:

Senior, Supply Chain Associate

Job Type:

Full-Time Position

Job Category:

Finance Accounting

Location:

Research Triangle Park, NC

Experience Required:

Minimum 5 years experience with Supply Chain Management within a pharmaceutical/biotechnology company or equivalent.

Education Level:

Bachelor’s degree

Role Purpose/Position Overview

Under the direction of the Director of Global Supply Chain Management and Logistics, handles sales order generation, supply chain and logistics services and US inventory evaluations.

Key Accountabilities/Responsibilities

• Evaluate purchase orders received from specialty pharmacy and works with third party contractors /warehouses to negotiate shipping dates.
• Perform sales order generation in SAP – the enterprise resource management system and communicates shipping requirements to the third party warehouses.
• Work with contractors to insure adequate levels of commercial drug products are available to meet current and future demands per the corporate goals.
• Evaluate and Schedule final Labeling of UTC produced Commercial drug batches based on market demands and/or trends
• Maintain commercial inventory movement and tracking reports
• Evaluate contract manufacturer commitments to ensure requirements are met.
• Assist with the coordination and communication of Global Supply Chain strategic operations sponsored programs.
• Assist in providing data analysis for production planning.
• Assist in developing logistics plans and supply chain procedures. Additional activities as deemed necessary by immediate supervisor.

Requirements

• BA/BS degree
• Minimum 5 years experience with Supply Chain Management within a pharmaceutical/biotechnology company or equivalent.
• Must be proficient PC or MAC; SAP or similar accounting/logistics Software; Literate with good Microsoft Office experience.
• 30% Travel.
• Excellent Communication and Diplomatic Skills to effectively work in collaboration with a variety of personalities and their respective responsibilities.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 16, 2011

Title:

Site Controller - RTP

Job Type:

Full-Time Position

Job Category:

Finance Accounting

Location:

Research Triangle Park, NC

Experience Required:

Minimum of 5 years of relevant work experience overseeing the finance/accounting departments (e.g. month-end close process, AP, inventory).

Education Level:

Bachelor's degree in Accounting or Finance from an accredited four-year college or university.

Role Purpose/Position Overview

This newly created position is responsible for managing the day-to-day accounting activities in RTP which include managing the AP group in RTP and the Cost Accountant (if located in RTP).  Other duties/projects may be assigned as needed.

Key Accountabilities/Responsibilities

Oversee day-to-day activities of Accounts Payable group including but not limited to the following:

• Review data entry of AP invoices and post AP invoice batches;
• Work closely with AP Manager in Silver Spring to ensure both AP teams follow the same policies and procedures;
• Vendor maintenance, as necessary;
• Prepare monthly Sales & Use tax reconciliations;
• Ensure vendor inquiries and other AP issues are addressed and resolved in a timely manner;
• Update Accounts Payable Standard Operating Procedures (SOPs) on a semi-annual basis;
• Coordinate quarterly internal control testing; and
• Liaison with RTP Financial Managers on AP or budget matters;
• This is a management position in the Finance department overseeing the AP team (3-4 members) and the Cost Accountant (1) if located in RTP [Note the cost accountant may be located in Silver Spring, MD].
• Position reports to the Controller in Silver Spring, MD.  Frequent interaction with Silver Spring Finance teams (e.g. GL and AP Managers) and frequent interactions with RTP budget managers, production and other departments.
• Not a budget manager; however, the role requires an astute eye to ensure expenditures are adequate and appropriate.

 Accounting responsibilities:

• Quarterly labor, building and cost center allocations;
• Assist with SEC filings (e.g. preparing and/or reviewing 10Q/10K support);
• Financial statement reviews;
• Special projects, as assigned.

 Manage cost accountant:

• Review journal entries for inventory, cost of sales, warranty reserve, etc.;
• Review inventory-related account reconciliations;
• Review standard cost calculations;
• Assist with the annual physical count in RTP, Silver Spring and Germany;
• Assist with the roll out of the SAP manufacturing project.
• Assist with the annual physical count in RTP, Silver Spring and Germany;
• Assist with the roll out of the SAP manufacturing project. 
• Assist with the annual physical count in RTP, Silver Spring and Germany;

Assist with the roll out of the SAP manufacturing project.

Requirements

• CPA preferred
• Minimum 5 years of relevant work experience overseeing the finance/accounting departments (e.g. month-end close process, AP, inventory).
• Minimum 3 years supervisory experience required.
• Applied knowledge of US GAAP.
• Practical cost accounting knowledge, a plus.
• Proficient with Microsoft Office suite of products.
• Experience with SAP or other ERP system, a plus. 
• Proficient with Microsoft Office suite of products.
• Experience with SAP or other ERP system, a plus.
• Monthly travel to Silver Spring, MD

.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 13, 2011

Title:

Sr. Accounts Payable Specialist

Job Type:

Full-Time Position

Job Category:

Finance Accounting

Location:

Research Triangle Park, NC

Experience Required:

3+ yearsf full cycle Accounts Payable experience required

Education Level:

High school diploma

Role Purpose/Position Overview

Processing Accounts Payable invoices in accordance with company SOP’s.

Key Accountabilities/Responsibilities

• Process all expenses with the proper GL account, Internal Order, Cost Center, and budget information. 
• Review employee expense entries in Concur.
• Process UTC and all subsidiary wires in Wachovia for mid-month, end of month and weekly OOC Payments.
• AP monthly reconciliations for all companies with the exception of Unither Telmed. Ltd. and Unither.com.
• Ensure all recurring payables and approved invoices received via the AP Mailbox are printed and entered for each cycle.
• Ensure all unapproved invoices received via the AP Mailbox are printed and routed out for approval.
• Ensure invoices are appropriately approved.
• Enter completed invoices into SAP accounting system.
• Ensure each vendor has a W9 on file.
• Resolve vendor related issues promptly and professionally.
• Meet A/P deadlines.
• Filing and maintaining AP vendor files in accordance to departmental policy.
• Assist Finance Department in all areas as needed.
• Other duties as assigned

Requirements

• Microsoft Excel efficiency preferred (Intermediate level)
• Experience with a general ledger accounting system required
• Very detail oriented
• Handle multiple tasks concurrently
• Excellent oral and written communications skills
• Strong interpersonal and organization skills
• Strong problem solving skills
• Able to work independently
• Able to follow instructions and guidelines
• Responsible for accurately coding invoices using GL chart of accounts.
• Responsible for utilizing company budget sheets to properly code invoices.
• Responsible for adhering to current company policies.
• Responsible for complying with changes and updates to policies, procedures, and company SOP’s.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 11, 2012

Title:

Sr. Quality Engineer

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Research Triangle Park, NC

Experience Required:

5+ years experience in Quality Engineering in the medical device industry

Education Level:

Bachelor’s Degree in Science or Engineering (or related field).

Role Purpose/Position Overview

The Senior Quality Engineer will be responsible for performing the product surveillance activities for medical devices, manufactured, marketed and distributed by United Therapeutics. Primary responsibility for all investigative and administrative activities associated with the complaint handling program including, but not limited to, driving complaint investigations and reviewing, managing and closing complaints records. This individual will evaluate product complaints related to the quality, reliability, safety, and effectiveness. Provides supports in the continuous improvement effort of the United Therapeutics quality system for processing complaints in order to meet FDA, ISO and all applicable international regulatory requirements.

Key Accountabilities/Responsibilities

• Investigate customer complaints following corporate SOP’s and documents into complaint management system.
• Lead complaint investigation activities.
• Collect, summarize and evaluate compliance performance metrics and work to identify program improvements.
• Participate in determination of reportability of complaints.
• Perform failure analyses and defect investigations.
• Review associated complaint records to ensure the applicable assessment and investigation records are created and completed.
• Ensure customer complaint response letters are completed in a timely and comprehensive manner if appropriate.
• Provide logistical support to Management Representatives during audits by regulatory or external and internal agencies.
• Communicate with Sales and Marketing teams, and other internal or 

• external customers to identify details related to complaint information and occurrence.
• Participates in the development of standard operating procedures.
• Participates in project teams as an extended team member to provide historical complaint information and participates in risk analysis activities
• Leads complaint reduction activities.
• Provide statistical guidance to test protocols/reports and ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
• Identify and manage risk through the product life cycle with the use of FMECA and/or other risk management tools.
• Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet specifications.
• Perform responsibilities required by the Quality System and other duties as assigned or requested.
• Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training) 

Requirements

• Bachelor’s Degree in Science or Engineering (or related field). 
• 5+ years experience in Quality Engineering in the medical device industry (or related industry). Experience in related engineering areas, e.g. R&D or Manufacturing is beneficial.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers and customers.
• Knowledge of FDA Quality System Regulation (21 CFR 820) and Medical Device Reporting Regulations (21 CFR 803, 806) and ISO 13485.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables simultaneously.
• Strong mechanical aptitude and methodical problem solving skills.
• Strong interpersonal, organizational, and project management skills.
• Proven self-motivation and leadership skills.
• Strong oral and technical writing skills.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 31, 2012

Title:

Staff Accountant

Job Type:

Full-Time Position

Job Category:

Finance Accounting

Location:

Research Triangle Park, NC

Experience Required:

Minimum of 2 years’ experience in accounting/finance, with a working knowledge of A/P, A/R, payroll, accounting systems (cash and accrual) and budget forecasting.

Education Level:

Bachelor of Science Degree in Accounting

Role Purpose/Position Overview

Responsible for supporting the Purchasing function whenever necessary, reconciliation of purchasing cards, and review and reconciliation of employee expense reports. Cross trained in A/P and specific finance function to serve as backup as required.

Key Accountabilities/Responsibilities

• Responsible for preparation of purchase orders and review of authorizations associated with purchase order requisitions.
• Responsible for reconciliation of purchasing cards as assigned.
• Responsible for review and reconciliation of expense reports submitted through Concur, assuring budget coding selections are accurate and distribution to approving supervisors and budget managers are accurate and complete.
• Provide contract assist for all contracts received with purchase order requisitions.
• Prepare ad hoc detailed analysis as directed to assist Budget
• Managers with decisions as required. 
• Prepare detailed analysis for Budget Managers as directed.
• Address month end and year end accounting questions from Corporate Accounting Finance Group in Silver Spring.
• Cross train on all finance- A/P functions to act as backup whenever needed.

Requirements

• Good working knowledge of accounting/finance activities with an aptitude for math
• Strong attention to detail as well as the “big picture”
• Excellent proofreading skills
• Good organization and problem-solving skills
• Excellent communication and interpersonal skills
• Team player and ability to interact with individuals from multiple disciplines
• Ability to maintain confidentiality
• Ability to work independently with minimal supervision as well as within a group/team
• Excellent knowledge and understanding of Microsoft Excel, Word, SAP, and SAS.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 19, 2011

Title:

Cost Accountant

Job Type:

Full-Time Position

Job Category:

Finance Accounting

Location:

RTP, NC OR Silver Spring, MD

Experience Required:

Must have 2 to 5 years experience as a cost accountant in a manufacturing enviornment. Biotech or pharmaceutical experience and applied knowledge of US GAAP is a plus.

Education Level:

Bachelor's degree from four-year College or university with a major in business, accounting, or finance.

Role Purpose/Position Overview

This position will perform activities covering materials and production costs, costs of sales and overhead.

Key Accountabilities/Responsibilities

The person in this position will:

• Analyze, monitor and reconcile inventory for approximately 4 companies (2 domestic/2 international)
• Timely processing of accumulated purchased and manufacturing costs for products manufactured and shipped during an accounting period.
• Develop and maintain standard costs for eligible products and product candidates.
• Develop as needed a reasonable and effective system to account for the cost of inventory maintained; raw materials, work-in-process, semi-finished and finished, and for calculating the cost of goods sold in our general ledger.  This also includes evaluating inventory reserves.
• Work with both internal and external responsible parties, as needed, to resolve inventory variances.
• Provide accounting assistance to Logistics and materials management, production personnel regarding raw material and other product costs.
• Assist with month-end close of the general ledger.
• Interact with independent auditors, contracted Internal Auditors and insurance broker regarding inventory, cost of goods sold, and production related matters.
• Other duties and projects as assigned.
• Assist other team members as needed.
• Assist with tax projects/requests.
• Additional duties as assigned by your manager to achieve company goals

Requirements

The ideal candidate will:

• Be detailed oriented and organized.
• Be able to work independently and as a team player.
• Have excellent communication skills (verbal and written)
• Possess strong analytical skills.
• Have time management skills and the ability to multi-task to complete areas timely and according to set quality standards.
• Demonstrate a good work ethic and attitude.
• Be able to sit for long periods of time while using the computer and telephone extensively.
• Be able to lift up to 35 pounds.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 12, 2011

Title:

Environmental Health & Safety (EHS) Specialist

Job Type:

Full-Time Position

Job Category:

Manufacturing

Location:

RTP, NC OR Silver Spring, MD

Experience Required:

3 - 5 years of relevant experience

Education Level:

Bachelor’s degree or equivalent experience and education.

Role Purpose/Position Overview

The position focus is on assisting the EHS Manager in addressing specific health, safety and environmental program elements to meet or exceed federal, state and local regulations, to meet UT’s goals of protecting its employees, the community and the environment.

Key Accountabilities/Responsibilities

• Conduct hazard evaluations of jobs and processes, and perform routine inspections of facilities and operations for unsafe conditions and work practices, and make recommendations to reduce / eliminate incident (re)occurrence.
• Perform workplace inspections to detect existing / potential chemical, biological and radiological hazards.
• Work with departmental staff to evaluate the adequacy of engineering and administrative controls, perform or coordinate industrial hygiene assessments and make recommendations through written technical reports.
• Plan, schedule, coordinate or conduct EHS Training Programs for employees and contractors such as HAZCOM, Blood borne Pathogens, Hazardous Waste Generator,  Laboratory Safety, Fire Protection and Prevention, DOT  HAZMAT requirements, etc.
• Assist in managing and maintaining day-to-day EHS programs, including Laboratory Assessments/Audits, New Hire Orientation, PPE distribution, etc.
• Conduct Accident Investigation and follow-up.

• Define trends associated with incidents that involve development of safety management systems to ensure continuous EHS improvement.
• Assist with ergonomic risk assessments of workplace / workstations, recommending corrective actions to reduce / eliminate hazards.
• Participate, manage and provide support for Site Safety Committees and safety related events.
• Assist with the management of the hazardous materials and waste program: work with department liaisons to safely and legally transport and dispose of hazardous waste per MDE, EPA and DOT regulations; maintain required training documents and certificates for employees involved in hazardous waste generation, transport and disposal; maintain records of disposal for UT waste;
• Perform hazardous waste inspections per MDE and EPA regulations and work with various departments to minimize violations while maintaining efficiency.
• Respond to emergency situations such as chemical spills, during business hours as well as after-hours and/or on weekends.
• Support other departments and other supportive duties as assigned.

Requirements

• Bachelor’s degree or equivalent experience and education.
• 3 - 5 years of relevant experience. 
• Good organizational skills and systems implementation. 
• GLP, cGMP, OSHA safety and internal safety procedures. 
• Experience in: Root cause analysis/CAPA training, contract negotiations & employee relations.
• Travel between the various company sites may be required.

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 19, 2011

Title:

Clinical Product Training Manager

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Home office – US

Experience Required:

5 years

Education Level:

Bachelor’s degree

Role Purpose/Position Overview

This position is responsible for assisting in the development, implementation, and execution of all technical and clinical training for our Distribution Supply Channel Partners and related Agencies on the disease(s) and effective treatments with UTC’s commercial products and to act as a corporate liaison.   Additional activities include supporting the Sales and Marketing Departments via the Regional Clinical Specialists (RCS) or directly with the Field Sales Teams related to interactions with Supply Channel Partner Clinicians.   Act as a consultant to the Marketing/Brand Teams during the development of branded materials for patient education. This position reports to the Director of Clinical Product Training.

Key Accountabilities/Responsibilities

Requirements

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

January 09, 2012

Title:

Medical Science Liaison - NE Region

Job Type:

Full-Time Position

Job Category:

Medical Affairs

Location:

Home office – US

Experience Required:

5+ years working in the biotech/pharmaceutical industry

Education Level:

Advanced scientific or clinical degree required

Role Purpose/Position Overview

The Medical Science Liaison serves as the primary field-based point of contact for current and future clinical investigators, speakers, and other health care providers on a range of clinical and scientific issues. The MSL for the Northeast will be responsible for the following states: ME, VT, NH, NY, MA, CT, RI, NJ and part of PA.

Key Accountabilities/Responsibilities

• Respond to unsolicited requests for information that is beyond the scope of that which is approved for promotional use while adhering to United Therapeutics policy on the dissemination of scientific information.
• Identify potential consultants and/or speakers for the company.  Train speakers on slides.  Ensure speaker programs are flawlessly executed (pre-meeting planning / post-meeting follow-up and evaluation) in collaboration with UT/Lung team.  Comply with United Therapeutics Standard Operating Procedures re. Speaker Programs.
• Primary contact between Pulmonary Arterial Hypertension (PAH) centers and internal depts. (i.e. Medical Affairs / Clinical Operations) with regard to company and investigator initiated studies ensuring scientific validity and alignment with company’s medical strategy.
• Establish and maintain relationships with current and future thought leaders by engaging in discussions related to publication concepts and advisory boards and responding to grants request and CME educational endeavors.
• Provide a medical / scientific training and support function for key internal stakeholders (CRA, field sales, marketing, etc;.
• Manage project work related to Medical Affairs activities and as assigned by the Senior Director/Director, Medical Affairs, including participation in building out of departmental infrastructure (eg, contributing to SOPs) and helping to realize departmental work stream efficiencies.

Requirements

• Advanced scientific or clinical degree (Pharm D., Ph.D., NP, MD) required.
• 5+ years working in the biotech / pharmaceutical industry (or appropriate clinical setting) or 2+ years working as an MSL or 3+ years in PAH.
• Ability to effectively communicate verbally and in writing scientific and medical information to a diverse audience of both internal and external personnel in small and large audience setting.
• Leadership, planning, communication, and organizational skills required.
• High energy level, self starter.
• Ability to work independently.
• Passion for consultation/teamwork.
• Ability to travel at least 65%.
• Ideal candidate will live within the NE territory of responsibility. 

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V