Own your opportunity to work alongside federal civilian agencies. Make an impact by providing services that help the government ensure the well being of U.S. citizens.
Job DescriptionSeize your opportunity to make a personal impact as a Senior Program Management Analyst (Science Field) supporting Defense Health Agency (DHA) Operational Medicine (OPMED). GDIT is your place to make meaningful contributions to challenging projects and grow a rewarding career.
Our work depends on a Senior Program Management Analyst joining our team and utilizing their experience and science background to ensure the medical countermeasures and treatments follow DoD requirements and able to meet the acquisition timeline to make it's way to the Warfighter.
HOW YOU WILL MAKE AN IMPACT:
Provide program/project management support to assigned IND medical products.Apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for force health protection missions. Work with the DHA Office of Regulatory Activities (ORA) to develop necessary regulatory documents and ensure IND protocols meet all regulatory requirements, such as supporting submission of documents for FDA. Interact with SMEs, appropriate IRBs, to gain IRB approval. Provide storage, protocol management, and oversee product release for FHP IND products entrusted to their care. Coordinate with multiple stakeholders to gather and analyze technically complex information, project management of therapeutics, prophylactics, diagnostics, and management of clinical protocols.Participate in Integrated Product Teams (IPTs) and working group meetings, as required.Coordinate meetings, lead working groups, develop and/or edit meeting minutes, develop technical reports, and assist with other tasks and deliverables as required.Support numerous efforts and effectively prioritize and multi-task on requirements that have a direct impact on the portfolio.Communicate with personnel at various echelons through the use of effective interpersonal and communication skills. Participate in special projects, as required.WHAT YOU NEED TO SUCCEED:
Education: Bachelor’s Degree in a biomedical, biological or regulatory science fieldRequired Experience: 8+ years of related experienceRequired Technical Skills: Understand Current Good Clinical Practice (cGCP), Current Good Laboratory Practices (cGLP) and Current Good Manufacturing Practices (cGMP), to apply knowledge of FDA requirements and procedures, especially Title 21 Code of Federal Regulations (CFR) regulations concerning IND protocols; Capable of applying knowledge in the area of DoD acquisition, force health protection, and clinical/FDA regulatory product development; Proficient with Microsoft (MS) Office 365 suite of applications, to include; MS Outlook, MS PowerPoint, MS Excel, MS Word, MS One Drive, MS TEAMS, and MS OneNote (SharePoint at an intermediate level)Security Clearance Level: No security clearance needed, however must be able to obtain a NACI (T1)Required Skills and Abilities: Excellent verbal and written communication skills; Be proactive and work both independently and in a team environmentPreferred Experience: Medical product management experience, including knowledge of applicable FDA regulations and experience with FDA submissionsLocation: Hybrid (on-site 3 days a week at Ft. Detrick, MD)Travel: Willingness to travel CONUS and OCONUSUS Citizenship RequiredGDIT IS YOUR PLACE
401K with company matchComprehensive health and wellness packagesInternal mobility team dedicated to helping you own your careerProfessional growth opportunities including paid education and certificationsCutting-edge technology you can learn from Rest and recharge with paid vacation and holidays#GDITPriority
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