Medical and Technical Advisor Support Specialist

Bering-Alaka`ina Holdings, LLC is looking for has a potential need for a Medical and Technical Advisor Support Specialist to provide support for our government customer in Frederick, MD at Fort Detrick Army Base.

• 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-sponsored and non-DoD-sponsored clinical research activities.
• Serve as a SME involved in the initial planning and development of the contract management plan; planning, designing, coordination, management, and conduct of clinical trial research, to include but not limited to protocols.
• Assist in the writing and preparation of clinical protocols and other clinical trial documents; serve as a key member of IPT.
• Provide expertise to aid in the development of the research strategy for clinical trials.
• Provide subject matter expertise in clinical trial site selection, site set-up, and subject recruitment and retention.
• Provide subject matter expertise to PjM/PdM regarding site investigator selection and issues related to clinical trial staff training; provide input on issues related to local clinical trial site administrative and operational issues, including the preparation of clinical trial agreements and site- and study-specific document.
• 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 as necessary 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 the 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; and keep current files of all information disseminated by the FDA and other policy bodies that affect products and will 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…