Senior Product Management Support I

Goldbelt, Inc.; Maryland; Hybrid; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Paid time off and professional dev.

Job summary

Goldbelt Apex seeks a Senior Product Management Support I to assist in managing therapeutics, diagnostics, and clinical protocols within a regulatory framework. The role involves coordinating FDA/IRB activities and leading cross-functional teams to ensure alignment with IND protocols and regulatory documentation.

The successful candidate will contribute to IND product accountability, protocol management, and related technical reports, while engaging stakeholders across the organization.

Qualifications

• Regulatory documentation and IND protocol management.
• Experience with FDA-regulated products and clinical programs.
• Clinical project and program management across cross-functional teams.

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop and 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

Regulatory documentation

IND protocols

Clinical project management

Cross-functional coordination

FDA-regulated products

Medical product development

Job description

Overview

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.

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

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.

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.