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Job Title: Scientific Program Manager
Job Number:
Organization: Reagan Udall Foundation for the FDA
Posted: 9/10/2019
Type: Full-Time
Classification: Biostatistics
Number of Openings: 1
Location: Washington,  DC    USA
Position Description: The Foundation is seeking a mission-driven Scientific Program Manager with an interest in joining a small and growing team. Duties will focus on providing project support to our flagship program, Innovation in Medical Evidence Development and Surveillance (IMEDS). The mission of IMEDS is to accelerate and improve real world evidence generation for the assessment of the risks/benefits of medical products. To achieve our mission, IMEDS creates and fosters multi-stakeholder public-private partnerships to evaluate safety and comparative effectiveness of medicines and devices. IMEDS partners include health systems, health plans, consumer advocates, pharmaceutical and biotechnology companies, academic organizations, NIH, and the FDA. Additional information about IMEDS can be found at medical-evidence-development-and- surveillance.

Reporting to the Scientific Director, the Program Manager will perform a broad range of administrative tasks and provide organizational support to ensure the smooth functioning of day-to-day operations and program development. The Program Manager will assist the Scientific Director in managing complex multi-stakeholder engagements that include organizing, scheduling, communications and contracting. The Program Manager engages daily with leaders in government, pharmaceutical industry and health systems. The ideal candidate will be a self-starter who is adept at working independently, thinking analytically, asking questions, and taking the initiative to identify gaps and propose solutions. Strong interpersonal skills, an ability to motivate a diverse team, as well as multi-task and prioritize activities are essential.

Duties and Responsibilities: • Assist the Scientific Director in program management of scientific activities of the Foundation, particularly IMEDS. These activities include managing multiple projects that involve meeting coordination, stakeholder engagement, contract negotiations and execution, timeline management, • Identify and propose management improvements to enhance productivity • Lead the tracking, reporting, and communications around project deliverables • Create and maintain standard operating procedures (SOPs) and other governance documents • Respond to calls and general inquiries about the program • Develop and coordinate Institutional Review Board Submissions and Data Use Agreements • Draft technical and public program reports, summaries and agendas. • Support the development of scientific manuscripts, abstracts and presentations. • Use project management principles to evaluate and report on study progress, identify problems, recommend solutions, and implement improvements • Manage relationships among diverse scientific and administrative partners from different sectors (Network Partners, Analytic Center, private industry and others), including maintaining project and business development contact lists

Qualifications: • Master’s Degree in a relevant field such as public policy, informatics, epidemiology, biostatistics, health economics, or public health • Minimum of 3 years of experience in project management • Familiarity with health systems data and/or clinical research • Sound knowledge of epidemiologic, analytic, and scientific research methods • Ability to demonstrate tact, diplomacy, patience, and initiative when working with project leaders inside and outside the organization • Demonstrated ability to quickly assess team members and adapt to/navigate varying communication styles • Demonstrated ability to communicate complex business and scientific issues succinctly and effectively in both written and oral formats. • Highly detail-oriented and deadline- driven, with superior organizational skills • Highly motivated to work independently, as well as in team settings • Demonstrated ability to maintain a customer centered focus and navigate the multi-stakeholder process of public-private partnerships • Must be reliable, creative, flexible and self-motivated

Desired Skills and Competencies: • Knowledge of information systems, diverse databases, and data analytics, specifically, health data systems (especially health record data) • Ability to keep sensitive information confidential • Proficiency with MS Office (Word, Excel, Access, PowerPoint and Outlook) and relevant web-based applications (e.g., Eventbrite, MailChimp, SurveyMonkey, Doodle), are required with an aptitude to quickly learn more advanced features, versions and other software; advanced Excel skills required

Organization Description: The Reagan-Udall Foundation for the FDA (the Foundation) is a non-profit organization that works to support the mission of the FDA by advancing regulatory science and research. The Foundation establishes public- private partnerships between FDA and external stakeholders to facilitate innovation in science and health.

Closing Date: 12/10/2019
Desired Starting Date:
Contact Name: David Woodbury,  Director of Operations
Contact Location: 1900 L Street, NW
Suite 835
Washington   DC  20036
United States
Contact Location: 1900 L Street, NW
  Suite 835
  Washington   DC  20036
  United States
Contact Phone: 202-849-2075 
Contact Fax:
Contact Email:
Web Address:
How to Apply: To apply for this position, please submit a resume, cover letter, and salary requirements to Relocation expenses are not provided.

Additional Information:

Web Site Delete Date: 12/10/2019