Arcetyp LLC is looking for a Senior Dod Medical Product Program Manager - Clinical & Regulatory. This position is onsite and located in Fort Detrick, MD.
ESSENTIAL JOB FUNCTIONS:
- Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
- Develop/review regulatory documentation.
- Coordinate FDA/IRB activities.
- Participate in and lead IPTs/working groups.
- Support IND product accountability, protocol management, technical reports, training, and stakeholder coordination.
- Investigational product/program management.
- FDA/IRB regulatory coordination.
- Clinical protocol management.
- GCP training and regulatory documentation.
- Stakeholder/IPT leadership.
- Product accountability and technical analysis.
NECESSARY SKILLS AND KNOWLEDGE:
- FDA-regulated medical product development.
- Investigational products.
- Clinical protocol/project management.
- Regulatory affairs and technical documentation.
- DoD medical acquisition environment.
MINIMUM QUALIFICATIONS:
- Knowledge of cGCP, cGLP, cGMP and Title 21 CFR.
- Ability to support IND regulatory requirements.
- Strong technical writing and stakeholder coordination.
- Travel: Up to 20%
PREFERRED QUALIFICATIONS:
- Current FHP incumbent.
- Direct experience with the existing FHP portfolio.
- DHA/DoD IND management.
- FDA submission and IRB coordination experience.
- Prior military medical countermeasure program support.
Min. Citizenship Status Required:
U.S Citizenship.
LOCATION:
Fort Detrick, MD
COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Pay and Benefits from our client: we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.
