10+ years of experience in medical product development or clinical trial research.
Bachelor's degree in a relevant field preferred.
Expertise in medical devices, diagnostics, drugs, and biologics.
Knowledge of DoD's acquisition process and regulatory compliance.
U.S. citizenship and background investigation required.
Responsibilities
Join a high-impact team supporting DoD medical research and product development.
Provide expert guidance on medical technologies and clinical research.
Attend site visits and participate in meetings with stakeholders.
Orchestrate regulatory strategies and compliance activities.
Review and analyze clinical protocols and safety data.
Facilitate understanding of FDA and DoD regulations for product development.
Assist in developing Clinical Practice Guidelines for trauma systems.
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 Medical Advisor 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: Medical Advisor Support Specialist
Position Location: Full-time on-site in Frederick, MD (Fort Detrick)
Daily Responsibilities:
Join a high-impact team advancing the Department of Defense's medical research and product-development mission. In this role, you will provide expert guidance on cutting-edge medical technologies, clinical research, regulatory strategy, and product development efforts that support Warfighters and military healthcare outcomes. Working alongside Government leaders, researchers, clinicians, and industry partners, you will help shape the path from scientific innovation to fielded medical capabilities that make a real difference in national defense and public health.
Provide expertise in the areas of medical devices, diagnostics, drugs and biologics, and/or other medical countermeasures; and/or blood and blood products/components and other medical solutions; and/or post-traumatic stress disorder and traumatic brain injury.
Provide clinical management expertise for both DoD- and non-DoD clinical research activities.
Attend and participate in site visits, IPT meetings and briefings, and sub-working group and investigator meetings.
Orchestrate the requisite regulatory strategy as well as organization and compliance activities as contained in appropriate DOD and DHA regulations, policies, pamphlets, and SOP.
Interact with stakeholders to assist in identifying, interpreting, prioritizing, and analyzing FDA, CFR, DoD, and DHA policies, regulations, and guidance documents as they relate to products in different stages of development.
Coordinate and assist with Joint Trauma System (JTS) to develop Clinical Practice Guideline(s) in support of the full rate decision or off-label use of the materiel solution.
Collaborate to identify regulatory affairs (RA) strategies will optimize product development.
Review and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data.
Facilitate an understanding of requirements for compliance with all applicable FDA regulations.
Understand and plan for future clinical trials and other pre-clinical trial milestones.
Coordinate and assist in the review of all pre-clinical trial documents.
Keep current files of all information disseminated by FDA and other policy bodies that affect products and interpret, synthesize, and incorporate the new information into the organization.
Assist in the development of a comprehensive Integrated Master Plan/IMS of FDA and non-FDA regulatory and clinical activities (e.g. tasks, documents, meetings,) to include estimated timelines required to support the product development of medical devices, drugs, biologics, blood and blood products and or other medical solutions.
Provide professional medical review of Investigational Device Exemption, IND protocols, IND packages, and plans for management of IND products.
Provide subject matter expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC).
Review technical documents (e.g., Master Production Records/Batch Production Records, testing protocols/reports, investigations, Corrective and Preventive Actions, etc.) and regulatory submissions (e.g., INDs, amendments, annual reports, protocols, IBs) as requested and provide feedback to the Product Manager.
Assess CMC related risk of commercial partners. Perform audits and GMP compliance advice.
Be a substantive participant in IPTs as a SME.
Provide expert written reviews, briefings, and recommendations for developmental medical projects to include reviewing and interpreting results.
At the end of data analysis, support scientific preparation of results for eventual publication in peer reviewed scientific journals or other media or publication.
Provide a medical/expert review of documents to be submitted to the FDA, EPA or other Governmental or Military organizations. Provide manuscript reviews for documents/reports submitted to scientific journals.
Required Years of Experience (min):
Minimum 10 years of relevant experience in medical product development/clinical trial research.
Required Degree/Certifications:
Bachelor's degree in a relevant area preferred
Required Experience & Expertise in the following areas:
Have the capability of applying knowledge of the DoD's acquisition process in conjunction with expertise in performance of all technical advisor support tasks.
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.
