5-7 years of experience in FDA-regulated medical product development
Strong understanding of investigational products and clinical protocols
Proven project management skills in a regulatory context
Expertise in regulatory affairs and technical documentation
Familiarity with the DoD medical acquisition environment
Knowledge of cGCP, cGLP, cGMP, and Title 21 CFR
Ability to support IND regulatory requirements
Responsibilities
Manage product and project activities for therapeutics and diagnostics
Develop and review essential regulatory documentation
Coordinate FDA and IRB activities effectively
Lead and participate in interdisciplinary teams and working groups
Oversee IND product accountability and protocol management
Ensure compliance with GCP training and regulatory documentation
Facilitate stakeholder coordination and technical analysis
Benefits
Comprehensive medical, dental, and vision insurance
401(k) plan with company matching
Tax-deferred savings options
Supplementary benefits
Paid time off
Professional development opportunities
Full Job Description
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.
