Senior Force Health Protection Product Manager (Consultant)

Bering-Alaka`ina Holdings, LLC; Frederick (MD); In loco; USD 110.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) match

Medical insurance

Dental insurance

Disability insurance

Life insurance

Tuition reimbursement

Paid time off

Holidays

Descrizione del lavoro

Bering-Alaka`ina Holdings, LLC is seeking a Force Health Protection (FHP) Senior Product Management Support Consultant to support our government customer in Frederick, MD at Fort Detrick Army Base.

Travel to CONUS and OCONUS locations may be required. Responsibilities include program management, regulatory documentation, and training on IND processes and FDA requirements, with coordination across DoD and IRBs.

Competenze

• Must have a medical, scientific, or technical degree or certification related to medical product development.
• Ability to apply cGCP/cGLP/cGMP knowledge to FDA IND protocols.
• Experience coordinating with DoD regulators and IRBs.

Mansioni

• Provide FHP program/project management support for government contract.
• Develop regulatory documentation and deliver GCP training for staff.
• Train on IND use and regulatory pathways for DoD personnel.
• Coordinate with stakeholders, prepare reports and meeting minutes.
• Ensure IND protocols meet regulatory requirements and FDA submissions.

Conoscenze

FHP PM

Regulatory docs

IND knowledge

cGCP/cGLP/cGMP

FDA requirements

IRB coordination

DoD regulations

Clinical research coordination

Formazione

Medical or advanced degree

Descrizione del lavoro

Bering-Alaka`ina Holdings, LLC is seeking a Force Health Protection (FHP) Senior Product Management Support Consultant to support our government customer in Frederick, MD at Fort Detrick Army Base.

Travel to CONUS and OCONUS locations may be required. Responsibilities include program management, regulatory documentation, and training on IND processes and FDA requirements, with coordination across DoD and IRBs.