- Location
- Frederick, MD, US
- Workplace
- Remote, Hybrid, Onsite
- Type
- Full-time
- Department
- IT
- Seniority
- Senior
- Experience
- 8+ years
- Education
- Master
- Visa
- Not sponsored
- Closing date
- Today
- Source
- iCIMS
Description
Position Summary
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***
Responsibilities
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***
Qualifications
Minimum Required Qualifications:
Citizenship: Must be a US citizen.
Clearance: Ability to Obtain NACI.
Education: Bachelor's 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
#LI-JC1
***Contingent upon contract award***
Company Overview
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 military’s 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
Please Note:
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.Odyssey Benefits