Clinical Trial/Medical Development Technical Advisor Support (Warfighter Protection and Acute Care) at Careers in US-MD-Frederick

Job description

• Odyssey is looking for a Technical Advisor Support (Warfighter Protection and Acute Care) , supporting the Defense Health Agency (DHA) at Ft. Detrick, MD. The Technical Advisor Support provides advanced clinical and scientific management expertise for DoD-sponsored clinical research activities within the WPAC division. This expert will assist in the planning, coordination, and conduct of clinical trials for medical devices, diagnostics, drugs, and biologics to treat acute care requirements.
• ***Contingent upon contract award***

Responsibilities

• Provide clinical management expertise for the planning, designing, coordination, management, and conduct of clinical trial research.
• Assist in the writing and preparation of clinical protocols and other clinical trial documents.
• Interpret, synthesize, and incorporate new information from the FDA and other policy bodies into organizational strategy.
• Assist in the development of comprehensive Integrated Master Plans for FDA and non-FDA regulatory and clinical activities.
• Advise product managers on the product development lifecycle, identifying regulatory requirements at each stage for drugs, biologics, and devices.
• Provide professional medical review of Investigational Device Exemptions, IND protocols and packages .
• Provide subject matter expertise in pharmaceutical quality/chemistry, manufacturing and controls (CMC) .
• Support scientific preparation of results for eventual publication in peer-reviewed journals.
• ***Contingent upon contract award***

Requirements

• Citizenship: Must be a US citizen.
• Clearance : Ability to Obtain NACI.
• Education: Advanced Degree in a medical, clinical, or scientific field.
• Years of Experience: At least 10 years of full-time work experience in medical product development and clinical trial research.
• In-depth knowledge of the development processes for drugs, biologics, and medical devices.
• Years of experience: Extensive experience interacting with the FDA and managing clinical trial protocols. And/or prior experience supporting military medical research and development. Experience with DHA/USAMMDA preferred

Skills

Required

• Clinical management expertise
• Knowledge of clinical trial research
• Development of Integrated Master Plans
• Product development lifecycle
• Scientific preparation for publication

Preferred

• Experience interacting with the FDA
• Managing clinical trial protocols
• Experience with DHA/USAMMDA

Benefits

• 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.