Medical and Technical Advisor Support-WRPBH

Systems Plus, Inc.; Frederick (MD); On-site; USD 120,000 - 160,000; Full time

Job summary

Systems Plus, Inc. seeks a senior regulatory and clinical development expert to guide DoD medical product programs from discovery through field deployment, collaborating with government leaders, researchers, clinicians, and industry partners.

You will shape regulatory strategy, oversee clinical research activities, and coordinate IMS planning to ensure compliant, timely product development for Warfighters and military healthcare outcomes.

Qualifications

• Medical degree or equivalent in a medical, scientific, or technical field.
• Minimum 10 years in medical product development or clinical trial research.

Responsibilities

• Provide expert guidance on medical technologies, clinical research, regulatory strategy, and product development for DoD programs.
• Attend IPT meetings, site visits, and briefings with government leaders and industry partners.
• Develop Regulatory Affairs strategies and Integrated Master Plans (IMS) for FDA and non-FDA activities.
• Review regulatory submissions (INDs, amendments, annual reports) and safety data.
• Support publication of results in peer-reviewed journals or other media.

Skills

Regulatory strategy

Clinical management

Stakeholder collaboration

FDA/DoD policy analysis

IP/IMS planning

Education

Medical degree or PhD

Job description

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.

Degree & Certifications: Possess a medical degree, doctorate, other advanced degree, or certification in a medical, scientific, or technical field related to the specific area of medical product development

Required Experience:

• Minimum 10 years of relevant experience in medical product development/clinical trial research.
• Have the capability of applying knowledge of the DoD’s acquisition process in conjunction with expertise in performance of all technical advisor support tasks.