Senior Product Management Support I (Force Health Protection)
Position: Senior Product Management Support I (Force Health Protection)
Location: Fort Detrick, MD
Work Environment: Hybrid / Telework Eligible (Routine and situational telework is authorized.)
Clearance Required: TIER 1: Non-critical sensitive position (Must be able to obtain and maintain)
Status: Contingent
Anticipated Salary Range: $120,000 - $160,000
Knowesis is seeking a Senior Product Management Support I for Force Health Protection (FHP) to oversee product management and clinical protocol accountability. This role manages Investigational New Drug (IND) products, ensures adherence to Good Clinical Practices (GCP), and coordinates with the FDA to support the clinical development of therapeutics and diagnostics.
The Job Duties and Responsibilities include but are not limited to the following:
- Develop regulatory documentation, organize, and provide annual and refresher Good Clinical Practices (GCP) training to medical and laboratory staff.
- Coordinate the management of clinical protocols, therapeutics, prophylactics, and diagnostics, ensuring compliance with FDA and DoD regulations.
- Work with the DHA Office of Regulated Activities to ensure IND protocols meet all regulatory requirements and support submissions to the FDA and Institutional Review Boards (IRB).
- Provide storage, protocol management, and oversee product release for FHP IND products.
- Review and analyze technical documents, making recommendations to ensure sound scientific processes are used in support of investigational products.
Required Qualifications:
- Bachelor's Degree in a scientific, health, or related field.
- At least 8 years of full-time work experience in clinical/FDA regulatory product development.
- Demonstrated experience and knowledge of Current Good Clinical Practice (cGCP), Current Good Laboratory Practices (cGLP), and Current Good Manufacturing Practices (cGMP).
Preferred Qualifications:
- Advanced degree in a scientific or health-related discipline.
- Extensive experience managing IND protocols and interacting with the FDA and IRBs.
Benefits:
- Health (PPO & HDHP) Insurance, Dental, Vision, STD & LTD, Basic Life Insurance, 401k Company Match, & Voluntary Products.
Knowesis is committed to providing equal employment opportunities to all individuals based on merit and qualifications. We prohibit discrimination in all aspects of employment as required by Title VII of the Civil Rights Act and other applicable federal laws. Our company values all applicants and employees and fosters a work environment where everyone is treated with respect and dignity.