Senior Product Management Support 2

About the role

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 Regulatory Affairs Support - WEMT.

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.

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 cG