8+ years of experience in DoD acquisition and medical product development
Bachelor's degree in a relevant field; advanced degree preferred
Experience with drugs, biologics, diagnostics, and medical devices
Knowledge of DoD acquisition processes and product-development lifecycles
Familiarity with FDA regulations and investigational medical products
Strong organizational and communication skills
Advanced proficiency in Microsoft Office 365 applications
Responsibilities
Drive development of next-generation medical products for Warfighter health
Support daily medical product development activities per DoD policies
Participate in Integrated Product Teams and program-management activities
Develop and maintain product-development documentation and schedules
Coordinate with diverse stakeholders to support product-development efforts
Manage clinical protocols and Force Health Protection initiatives
Conduct product evaluations and market research
Benefits
Direct hire full-time position
Competitive base salary and comprehensive benefits
Opportunities for growth in a mid-size company
Full Job Description
Computer Technologies Consultants (CTC) is seeking a Senior Product Management Support Specialist to support the Defense Health Agency (DHA) at Fort Detrick, MD.
Why Should You Be Interested?
Direct hire full-time position
Competitive base salary and comprehensive benefits
Mid-size company with room for growth
Position Title: Senior Product Management Support Specialist
Position Location: Full-time on-site in Frederick, MD (Fort Detrick)
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.
Required Years of Experience (min):
Minimum eight (8) years of experience supporting DoD acquisition, medical product development, product management, program management, or related federal acquisition programs.
Required Degree/Certifications:
Bachelor's degree in a relevant area; advanced degree preferred
Required Experience & Expertise in the following areas:
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
Pay Information
Full-Time Salary Range: TBD
Please note: This range is based on our market pay structures. However, individual salaries are determined by a variety of factors including, but not limited to: business considerations, local market conditions, and internal equity, as well as candidate qualifications, such as skills, education, and experience.
