GAP SOLUTIONS INC

Scientific Program Manager (Regulatory Affairs) (51824)

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Position Objective: The Scientific Program Manager will provide support to the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH).

Duties and Responsibilities:

  • Serve as a regulatory affairs management expert. Responsible for managing an Investigational New Drug (IND) application portfolio of products consisting of vaccines and monoclonal antibodies for compliance with the Food and Drug Administration (FDA) regulations for use of investigational products in humans. 1
  • Serve as an expert on all regulatory matters concerning the development of vaccines and monoclonal antibodies. This involves strategy, implementation, review processes, submissions and compliance with the FDA, National Institutes of Health (NIH) and international regulatory authority regulations. 2
  • Provide recommendations to the office Director on optimal strategies to advance candidate products to the clinic. 3
  • Write and review documentation for compliance with FDA current Good Clinical Practice (cGCP), Good Laboratory Practice (GLP), and/or current Good Manufacturing Practice (cGMP). These documents include, but are not limited to, clinical study protocols, informed consent documents, to ensure test plans encompass all required test elements, data parameters, test objectives, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries.
  • Responsible for the management and quality of the Investigational New Drug (IND) application and amendments throughout its lifecycle which includes writing, reviewing and/or editing the initial IND submission, IND amendments, Investigator Brochures and FDA annual reports.
  • Interact with FDA project managers routinely. Responsible for pre-pre and pre-IND meetings and meeting packages, and responses to FDA queries.
  • Develop standard operating procedures, evaluate emerging regulations and changing regulatory landscape for impacts, provide strategic advice, and communicate with stakeholders which may include recommending applicable education and training to personnel for assurance of regulatory compliance.
  • Serve as liaison between the Office and other components involved in product development. Serve on product development teams as the regulatory expert.
  • Prepare detailed reporting to the Director to ensure Sponsor responsibilities are met.
  • This reporting includes but is not limited to the development of adequate clinical monitoring plans, adherence to the study protocol, product accountability, safety of human subjects, validity of data, and compliance with regulatory requirements.
  • Provide strategic regulatory support and advice to external collaborators (including licensing partners) that are using VRC investigational products, to facilitate advanced development and to ensure VRC Sponsor responsibilities as manufacturer are met.
  • Provide regulatory Intelligence by monitoring, gathering, and analyzing of publicly available and experience-based regulatory information needed to develop a strategy for drug development and risk mitigation.
  • Conduct literature and product reviews to inform product development strategy, reviewing and interpreting scientific and technical information, scientific and technical writing, ensuring compliance with regulatory requirements, study data collection management, and preparation or editing of scientific documents and publications.
  • Manage complex systems for data management and document control; supporting the dissemination of information on vaccine, monoclonal antibody, and other VRC clinical trials and collaborations using VRC products; and responds to related inquiries by sites, sponsors, FDA, and international regulatory agencies.
  • Respond to infectious disease outbreaks and pandemic, emphasizing the urgency and importance the VRC mission.
  • Meet with lab members to present updates