Senior Product Management Support 2

Goldbelt Apex, LLC; Frederick (MD); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company matching

Tax-deferred savings options

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex is seeking a Regulatory Affairs Support - WEMT to contribute to FDA/IRB coordination and regulatory documentation in a DoD-focused clinical environment.

The role emphasizes management of investigational products and clinical protocols, with opportunities to lead IPTs and support IND requirements.

Qualifications

• Knowledge of FDA-regulated medical product development and regulations.
• Experience with investigational products and regulatory documentation.
• Ability to manage clinical protocols and project coordination.
• Familiarity with cGCP/cGMP and Title 21 CFR is a plus.

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop and review regulatory documentation.
• Coordinate FDA/IRB activities.
• Lead IPTs/working groups.
• Support IND product accountability, protocol management, technical reports, and stakeholder coordination.
• Manage investigational product/program oversight.
• FDA/IRB regulatory coordination.
• Clinical protocol management.
• GCP training and regulatory documentation.
• Stakeholder IPT leadership.
• Product accountability and technical analysis.

Skills

Regulatory affairs

IND/IRB coordination

Clinical protocol management

Technical writing

DoD regulatory environment

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.

Summary

Goldbelt APEX is looking for a Regulatory Affairs Support - WEMT.

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.
• Investigational product/program management.
• FDA/IRB regulatory coordination.
• Clinical protocol management.
• GCP training and regulatory documentation.
• Stakeholder/IPT leadership.
• Product accountability and technical analysis.

Qualifications

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.

Pay and Benefits

The annual salary for this position is $95,000 to $135,000.

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.

• 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