What are the responsibilities and job description for the Senior Product Management Support (FHP) position at Systems Plus, Inc.?
Daily Responsibilities:
Help drive the development of next-generation medical products that protect and enhance Warfighter health and readiness. As a Senior Product Management Support professional, you will work alongside military leaders, clinicians, researchers, and industry partners to advance innovative drugs, biologics, medical devices, and other critical healthcare solutions from concept through deployment. This role offers a unique opportunity to influence high-visibility programs at the intersection of acquisition, science, technology, and national defense.
- Support day-to-day medical product development activities in accordance with DoD acquisition policies, DHA guidance, and applicable regulatory requirements.
- Participate in and support Integrated Product Teams (IPTs), Working Groups, Product Manager meetings, In-Process Reviews (IPRs), Milestone Decision Reviews (MDRs), and other acquisition and program-management activities.
- Develop, coordinate, and maintain product-development documentation, including schedules, briefing materials, executive summaries, meeting minutes, reports, action-item trackers, and other program records.
- Coordinate with government, military, industry, academic, and clinical stakeholders to gather, analyze, and present technical, programmatic, and regulatory information supporting product-development efforts.
- Support the development, management, and execution of clinical protocols, investigational-product activities, and Force Health Protection product-development initiatives.
- Coordinate product evaluations, market research, technology assessments, site visits, testing activities, and responses to external requests for information.
- Work with regulatory, clinical, and medical stakeholders to support IND-related activities, FDA submissions, regulatory compliance efforts, and the management of investigational products.
- Review and analyze technical, scientific, regulatory, and program documentation and provide recommendations to Product Managers regarding product-development, acquisition, and regulatory activities.
- Support training development and delivery related to Good Clinical Practice (GCP), investigational products, regulatory pathways, and product accountability processes.
- Maintain program records, action items, taskers, and acquisition documentation within approved electronic document-management systems while ensuring timely completion of assigned deliverables.
Degree: Bachelor’s degree in a relevant area; advanced degree preferred
Required Experience:
- Minimum eight (8) years of experience supporting DoD acquisition, medical product development, product management, program management, or related federal acquisition programs.
- Experience supporting medical product development and acquisition programs involving drugs, biologics, diagnostics, medical devices, medical countermeasures, or other regulated healthcare products.
- Knowledge of DoD acquisition processes, product-development lifecycles, and Integrated Product Team operations.
- Familiarity with FDA regulations, IND protocols, GCP, cGMP, cGLP, and applicable regulatory pathways supporting investigational medical products.
- Ability to prepare and maintain technical, regulatory, acquisition, programmatic, and executive-level documentation and briefings.
- Ability to analyze complex scientific, medical, regulatory, and acquisition information and communicate findings to Product Managers and senior leadership.
- Strong organizational, communication, stakeholder-engagement, task-management, and problem-solving skills.
- Advanced proficiency with Microsoft Office 365 applications, including Word, Excel, PowerPoint, Teams, SharePoint, and Project.
- Ability to support CONUS and OCONUS travel as required.
Required Clearance:
- U.S citizenship required
- Background investigation