Senior Product Management Support I

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Tax-deferred savings options

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex LLC is seeking a Senior Product Management Support I to assist in managing therapeutic, prophylactic, and diagnostic programs and to coordinate regulatory documentation and FDA/IRB activities.

The role requires strong cross-functional collaboration, regulatory knowledge, and hands-on experience in IND protocol management and clinical program coordination. Travel up to 20% may be required, with a competitive salary and benefits package.

Qualifications

• Understanding of cGMP, cGCP, and cGLP in practice.
• Knowledge of FDA requirements and Title 21 CFR for INDs.
• Experience with regulatory documentation and clinical programs.
• Ability to coordinate cross-functional teams across disciplines.

Responsibilities

• Support product/project management for therapeutics, prophylactics, diagnostics, and protocols.
• Develop and review regulatory documentation.
• Coordinate FDA/IRB activities.
• Lead IPTs and working groups.
• Support IND product accountability and protocol management.

Skills

Medical product dev

FDA-regulated programs

IND protocols

Regulatory docs

Clinical project mgmt

Cross-functional coord

Job description

Overview

Please note that this position is contingent upon the successful award of a contract currently under bid.

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary

Goldbelt APEX is looking for a Senior Product Management Support I.

Responsibilities

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.

Qualifications

Necessary Skills and Knowledge:

• Medical product development.
• FDA-regulated products and clinical programs.
• IND protocols.
• Regulatory documentation.
• Clinical project/program management.
• Cross-functional stakeholder coordination.

Minimum Qualifications:

• Ability to understand and apply cGCP, cGLP, and cGMP.
• Knowledge of FDA requirements and Title 21 CFR applicable to IND protocols.
• Knowledge of DoD acquisition, Force Health Protection, and clinical/FDA-regulatory product development.
• Travel: Up to 20%

Preferred Qualifications:

• Current FHP incumbent.
• DHA Office of Regulated Activities experience.
• IND product/protocol management experience.
• IRB interaction/approval experience.
• Military medical countermeasure experience.
• CONUS/OCONUS operational support experience.

Pay and Benefits

The annual salary for this position is $95,000 to $125,000.

At Goldbelt, 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.

• medical, dental, and vision insurance
• a 401(k) plan with company matching
• tax-deferred savings options
• supplementary benefits
• paid time off
• professional development opportunities