Senior Product Manager – Clinical & Regulatory Support

Goldbelt, Inc.; Frederick (MD); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Professional development

Job summary

Goldbelt Apex, part of the Healthcare Technology Transformation Group, is seeking a Senior Product Management Support I to assist in regulatory documentation, clinical program management, and cross-functional coordination across therapeutics and diagnostics.

The role involves FDA/IRB coordination, IPT participation, and IND protocol oversight, with travel up to 20% and a salary range reflected in benefits package.

Qualifications

• Must understand and apply cGCP, cGLP, and cGMP.
• Knowledge of FDA requirements and 21 CFR applicable to IND protocols.
• Knowledge of DoD acquisition, Force Health Protection, and clinical/FDA-regulatory product development.

Responsibilities

• 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.

Skills

Medical product development

FDA-regulated products

IND protocols

Regulatory documentation

Clinical project management

Cross-functional coordination

Job description

Goldbelt Apex, part of the Healthcare Technology Transformation Group, is seeking a Senior Product Management Support I to assist in regulatory documentation, clinical program management, and cross-functional coordination across therapeutics and diagnostics.

The role involves FDA/IRB coordination, IPT participation, and IND protocol oversight, with travel up to 20% and a salary range reflected in benefits package.