Senior Product Management Support 2

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

Benefits offered by this job

Medical Insurance

401(k) plan with company matching

Paid time off

Job summary

Goldbelt Apex is seeking a Regulatory Affairs Support – WEMT to help manage regulatory documentation, coordinate FDA/IRB activities, and lead IPTs within the DoD medical acquisition environment.

The role emphasizes cGXP compliance, IND requirements, and strong technical writing, with up to 20% travel. A comprehensive benefits package accompanies the base salary range.

Qualifications

• Regulatory affairs knowledge for FDA-regulated products.
• Strong technical writing and documentation skills.
• Experience coordinating stakeholders and IPTs/working groups.
• Willingness to travel up to 20%.

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

Skills

Regulatory affairs knowledge

Technical writing

Stakeholder coordination

Travel readiness

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. 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.