Senior DoD Medical Product Program Manager – Clinical & Regulatory - Telework

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.