Senior Product Management Support (Force Health Protection)

Odyssey is looking for a a Senior Product Management Support for Force Health Protection (FHP) to support the Defense Health Agency (DHA) at Ft. Detrick MD. This role provides vital oversight of product management and clinical protocol accountability. It also 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.

***Contingent upon contract award***

Duties include but are not limited to:

• 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.

***Contingent upon contract award***

Minimum Required Qualifications:

Citizenship: Must be a US citizen.

Clearance: Ability to Obtain NACI.

Education: Bachelors Degree in a scientific health or related field.

Years of Experience: At least 8 years of full-time work experience in clinical/FDA regulatory product development.

Certifications: Demonstrated experience and knowledge of Current Good Clinical Practice (cGCP) Current Good Laboratory Practices (cGLP) and Current Good Manufacturing Practices (cGMP).

Preferred Qualifications:

Education: Advanced degree in a scientific or health-related discipline.

Years of experience: Extensive experience managing IND protocols and interacting with the FDA and IRBs.

Experience with DHA/USAMMDA preferred

Location: Defense Health Agency (DHA) 1430 Veterans Drive Fort Detrick MD 21702

Travel: 10%

Remote Onsite or Hybrid: Onsite

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***Contingent upon contract award***

Odyssey is a world-class technical engineering and integration company serving the warfighting ecosystem with airborne integration ISR C2 and warfighter readiness capabilities. Odyssey meets the militarys operational needs by integrating layered defense systems from equipment technology and services to data information and business operations. We streamline defense acquisition and sustainment engineering the technical battlefield with domain-specific proficiency to ensure lethality. Odyssey is dedicated to excellent contract execution peak organizational performance and fostering a workplace built on employee care.

Odyssey is proud to live out our core values of commitment ambition and respect in our work and communities through OdysseyCares a philanthropic group focused on giving back through direct donations an employer match program and volunteering events.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates relevant work experience specific skills and competencies geographic location education and certifications.

This position is filled through continuous recruitment and will remain open until a sufficient pool of applications has been received.

Hired applicants may be eligible for benefits including but not limited to medical dental vision life insurance Tricare supplement short-term disability long-term disability 401(k) match flexible spending accounts health savings accounts employee assistance program learning and development benefit paid time off and holidays.

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