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Got the Government Contractor Blues? Looking for a company that cares and goes beyond just filling another contract billet? Well, look no further! Experience this family-oriented company that takes pride in you and will help you grow where your passions lie. Holding many Defense & Federal government contracts around the globe, with Systems Plus, you have the opportunity to take on new and evolving challenges, aim beyond what you think you are capable of, and work in collaborative, dynamic, and high-tempo environments. Our employees are our most valued asset, and we invest in our people because we are in it for the long term. We are committed to your success and well-being and offer competitive benefits packages, salaries, bonus/award programs, and a high potential for professional growth and job opportunities worldwide. Systems Plus is the company for you! Experience the difference, and let's talk about your future at Systems Plus today. Position Title Senior Product Management Support (FHP) Position Type Full-Time, Hybrid Position Location Frederick, Maryland Tracking Code 01242 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 and Certifications:

• 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 About Systems Plus Systems Plus is headquartered in Rockville, MD with over 2 decades of experience providing Global Enterprise Management, Technology, Engineering and Professional services and solutions across Defense and Federal Civilian government sectors.

From Discovery to Delivery, Systems Plus brings a greater measure of confidence, commitment and value to our clients. With various Defense and Federal contracts across the United States, Europe and Pacific/Asia, we are driving innovation and excellence within the Special Operations Forces Components and Commands, Defense Health Agency, United States Air Force, United States Marine Corps, National Institute of Standards and Technology, House of Representatives and more. Through our diverse portfolio of clients and capabilities we power vision and insight—discover what's possible with a Small Business that thinks BIG! Interested individuals should email their resume with salary expectations and with a cover letter to [email protected] .