Lung Rx

Date:

July 29, 2010

Title:

Associate Director, North American Regulatory

Job Type:

Full-Time Position

Job Category:

Regulatory

Location:

Silver Spring, MD

Experience Required:

10 years pharmaceutical exp, FDA or with a regulatory CRO.

Education Level:

Bachelors, Masters or Doctoral degree in the appropriate scientific disciplines or an undergraduate or graduate degree in Pharmacy.

Role Purpose/Position Overview

The Associate Director of North American Regulatory Affairs is responsible for developing US regulatory strategy, providing regulatory advice and oversight to project teams and supporting regulatory submissions.

Additionally, this position is responsible for providing strategic and operational leadership in the area of advertising and promotion primarily pertaining to US marketing activities.

Key Accountabilities/Responsibilities

• Support the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial development of new products.
• Serve as the US Regulatory Affairs representative on project teams, interpreting issues and advising the project team on the application of regulations.
• Manage the internal review of regulatory submissions and assure that all submissions meet the highest regulatory standards.
• Serve as the primary contact for the communication with the FDA in regard to the preparation and the submission of INDs, NDAs, Orphan Drug documentation and other required submissions.
• Act as the regulatory liaison with co-promote partners regarding promotional review and serve as the primary Lung Rx regulatory reviewer for promotional materials to assess for compliance with the promotional regulations and guidance documents.
• Represent the regulatory perspective at promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Legal.
• Develop, implement and maintain regulatory procedures regarding review of advertising and promotional materials for US marketed products.

Requirements

• Must have extensive relevant experience with FDA submissions in the US.
• Successful achievement in managing regulatory aspects of development programs and projects within the pharmaceutical industry.
• Must understand regulations and guidelines governing pharmaceutical product development including ability to apply these to overall strategic drug development.
• Experience in effective management of third party contractors.
• Demonstrated effectiveness in delivering outcomes and reaching milestones.

Qualified candidates please click here to apply!

EOE

Date:

July 19, 2010

Title:

Principal Sales Operations Analyst

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Silver Spring, MD

Experience Required:

6+ years sales operations experience

Education Level:

BS in Information System, Engineering (Electrical, Mechanical, or Aerospace), Computer Science, Math, or other advance technical/ science degree

Role Purpose/Position Overview

The Principal Sales Operations Analyst will support Commercial Affairs activities by creating, analyzing and producing reports in a timely manner that track and monitor a variety of sales performance and activity, including sales results, calls, reach and frequency, and budgets.

Key Accountabilities/Responsibilities

• Responsible for managing Sales Force Automation (SFA) system
• Responsible for managing key projects in the Commercial Affairs Department relating to vendors and data management for sales reporting.
• Accountable for developing, managing, and monitoring departmental expenses and budgets.
• Oversee the execution of the tactical and operational segments of the sales plan for all marketed products by the sales force.
• Actively participate and make recommendation refinement to promotional strategies, sales implementation, business plans and sales forecasts based on reports, analyses, and data generated from the sales force reporting systems.
• Select and negotiate with selected vendors, acting as liaison on matters of bids, pricing, contracts, etc. under the supervision of the Director of Sales Operations.
• Partnership with Shared Services and manage a variety of internal and external customers to facilitate the flow of information throughout the company for improvement of sales processes.

Requirements

BS in Information System, Engineering (Electrical, Mechanical, or Aerospace), Computer Science, Math, or other advance technical / science degree

• Project Management / Vendor Management
• Data processing / automation programming
• Relational database administration Preferred
• Pivot table analysis
• SAS automation Preferred
• Technical Requirements: Advance knowledge of MS Office (Word, Excel, PowerPoint, Access); VB for Application; ASP.NET
• Technical experience preferred: SQL Server administration / programming; web application development
• Must be willing to travel as needed to meet with external vendors, distributors, and in support of regional / national meetings

Qualified candidates please click here to apply!

EOE

Date:

July 27, 2010

Title:

Training Manager

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Silver Spring, MD

Experience Required:

Must have experience managing a team –or—experience being on a training force while managing a territory (dual responsibility)

Education Level:

BA/BS required

Role Purpose/Position Overview

The Training Manager will have a critical role in identifying the training needs and objectives for the ongoing development of our field personnel. The Training Manager will create coursework related to disease state training, selling skills and develop tools to reinforce the marketing strategy.   In addition, the Training Manager of Training will create coursework for the current leadership development program.  A position which requires exceptional selling skills, facilitation skills, evidence of coaching & mentoring others.  Strong cardiovascular and pulmonary disease state knowledge is required. The scope of responsibility lies within the (Silver Spring, MD) corporate headquarters location with travel throughout the nation to enhance existing hires’ selling skills and scientific knowledge.

Key Accountabilities/Responsibilities

Classroom Training: 30%

• Aid in the design, development, and delivery of training modules for new field personnel
• Participate in the planning and implementation of in-house new hire and advanced training classes
• Assist Sales Directors by conducting field visits with filed sales personnel

 Training and Development: 40%

• Assist Sales Directors to identify training needs
• Plan, develop and conduct workshops at POA and National meetings
• Identify and promote field “best practice” knowledge and skill requirements
• Conduct field coaching visits with experienced sales reps as needed

 Marketing: 20%

• Participates in the marketing planning process and implementation of marketing initiatives by developing training so that reps can properly deliver the marketing core messages.

 Corporate Training Initiatives: 10%

• Help to develop a corporate training department in identifying future needs of the company
• Participate in ongoing assessment of training needs
• Coordinate meeting planning and logistics as necessary

Requirements

* Must possess high level of technical knowledge and aptitude for scientific material.

* Demonstrated ability to teach and train others complex technical information, selling skills, and business and management concepts.

* Ability to convey complex scientific information in an easy-to-learn format.

* Demonstrated initiative and leadership qualities.

* Ability to manage time and multiple tasks effectively.

* Must have experience managing a team –or—experience being on a training force while managing a territory (dual responsibility).

* Previous training experience preferred.

* Must have demonstrated outstanding results in a sales position.

* Proficient in Word, Excel, Power Point and other commonly used programs. Must be adept at creating and delivering effective presentations.

* Overnight travel up to 60%

Qualified candidates please click here to apply!

EOE