Technical Advisor Support

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 that takes pride in you and will help you grow where your passions lie. Holding many Defense & Federal government contracts around the globe, with Systems Plus, 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 employees are our most valued asset, and we invest in our people because we are in it for the long term. We 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 worldwide.

Systems Plus is the company for you! Experience the difference, and let’s talk about your future at Systems Plus today.

Full-Time, Onsite

Frederick, Maryland

01224

Join the team supporting one of the Department of Defense’s premier biotechnology innovation initiatives, helping advance breakthrough technologies in regenerative medicine and biomanufacturing. Bring your medical, scientific, and regulatory expertise to high-impact programs developing next-generation medical devices, diagnostics, drugs, biologics, and other medical countermeasures. You will advise product teams, shape clinical and regulatory strategies, evaluate technical and safety data, and provide expert recommendations that help advance innovative medical solutions for the warfighter.

• 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…