Medical Advisor Support- 3691004

Computer Technologies Consultants (CTC) is seeking a Medical Advisor Support Specialist to support the Defense Health Agency (DHA) at Fort Detrick, MD.

With offices in Washington DC and San Diego, CA, CTC is a leading technology company providing lifecycle IT, data analytics, cloud managed hosting services, agile software development, DevOps, Test Automation, Cyber Security, and infrastructure solutions. Additionally, we provide Professional Talent Acquisition Services as we proudly support the unique needs of U.S. Defense, Intelligence, and Federal Civilian agencies as well as Fortune 1000 companies.

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 who takes pride in you and will help you grow where your passions lie. Holding many Defense & Federal government contracts around the globe, with our client 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 clients' employees are their most valued asset and they invest in their people because they are in it for the long term. They 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 world-wide.

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.

Computer Technologies Consultants, Inc. is an Equal Opportunity Employer that provides employment opportunities for all qualified applicants without regard to race, color, religion, gender identity and/or expression, sexual orientation, age, mental or sensory differing abilities, protected veteran status, sex, national origin, or any other characteristic protected by applicable law. Computer Technologies Consultants, Inc. is devoted to diversity, equity, and inclusion.