Senior Product Management Support 2
The Senior Product Management Support role at Confidential Client involves supporting regulatory affairs and project management for FDA-regulated medical products including therapeutics and investigational products. The position requires coordination of FDA and IRB activities, clinical protocol management, and leadership in cross-functional teams to ensure compliance with regulatory standards and effective stakeholder communication. This role is critical in managing investigational product accountability and supporting regulatory documentation within a DoD medical acquisition environment.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Health and Human Services.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Role Overview
Confidential Client is seeking a Senior Product Management Support 2 to provide regulatory and program support for FDA-regulated medical products, investigational products, and related clinical protocols in a DoD medical acquisition environment. This role supports IND management, FDA/IRB coordination, technical documentation, stakeholder engagement, and product accountability.
What You’ll Do
- Support product and project management for therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols
- Develop, review, and maintain regulatory documentation for FDA/DoD submissions
- Coordinate FDA and Institutional Review Board (IRB) activities and related communications
- Lead and participate in Integrated Product Teams (IPTs) and working groups
- Support IND product accountability, protocol management, technical reports, and training
- Manage investigational product logistics and program-level coordination
- Provide GCP training and ensure regulatory documentation compliance (cGCP, cGLP, cGMP, Title 21 CFR)
- Serve as a point of contact for stakeholders; drive coordination across technical, clinical, and program teams
- Travel up to 20% as required
Qualifications
Necessary Skills and Knowledge
- Experience with FDA-regulated medical product development and investigational products
- Clinical protocol and project management experience
- Regulatory affairs experience, including technical documentation and submission support
- Familiarity with DoD medical acquisition environment and processes
- Strong technical writing and stakeholder coordination skills
Minimum Qualifications
- Working knowledge of cGCP, cGLP, cGMP and Title 21 CFR
- Ability to support IND regulatory requirements and IND product accountability
- Proven experience producing and reviewing regulatory documentation
- Willingness/ability to travel up to 20%
Preferred Qualifications
- Prior work as an FHP incumbent or direct experience supporting an FHP portfolio
- Experience with DHA/DoD IND management and FDA submission/IRB coordination
- Prior support for military medical countermeasure programs
Pay & Benefits
- Annual salary range: $95,000 to $135,000 (salary commensurate with experience)
- Competitive benefits package including medical, dental, and vision insurance, 401(k) with company match, tax-deferred savings options, supplementary benefits, paid time off, and professional development support.
Additional Details
- Employment type: FULL_TIME
- Education: Bachelor’s degree (per source)
- Location: Frederick, MD (on-site or as required by program)
- This position is contingent upon the successful award of a contract currently under bid.
- All references to the hiring entity are listed as Confidential Client in this posting.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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