Job description
Overview:
Summary:
Goldbelt Frontier, LLC is looking for a Medical Advisor to support the United States Army Medical Materiel Development Activity (USAMMDA), a subordinate command under United States Army Medical Research and Development Command (USAMRDC) in Frederick, MD.
As the Medical Advisor, you will support our government customer with the Medical Research, Development, Test, and Evaluation (RDT&E) phases of the acquisition life cycle for devices, equipment, and systems used to support the United States Army Medical Materiel Development Activity (USAMMDA). USAMMDA is responsible for developing medical products such as drugs, vaccines, devices, and medical support equipment. USAMMDA preserves and protects the lives of warfighters by developing medical products to ensure readiness and the highest quality of medical care for DOD personnel.
Responsibilities:
Qualifications:
Goldbelt Frontier fosters a collaborative environment where employees are encouraged to utilize and employ their operational and leadership skills. Many senior project managers and business analysts are subject matter experts in their respective fields. Frontier understands how to support multiple stakeholders to aid in developing and implementing national policies, strategies, and doctrine.
Summary:
Goldbelt Frontier, LLC is looking for a Medical Advisor to support the United States Army Medical Materiel Development Activity (USAMMDA), a subordinate command under United States Army Medical Research and Development Command (USAMRDC) in Frederick, MD.
As the Medical Advisor, you will support our government customer with the Medical Research, Development, Test, and Evaluation (RDT&E) phases of the acquisition life cycle for devices, equipment, and systems used to support the United States Army Medical Materiel Development Activity (USAMMDA). USAMMDA is responsible for developing medical products such as drugs, vaccines, devices, and medical support equipment. USAMMDA preserves and protects the lives of warfighters by developing medical products to ensure readiness and the highest quality of medical care for DOD personnel.
Responsibilities:
Essential Job Functions:
- Provide expertise in the areas of devices, diagnostics, vaccine technology, therapeutics (e.g., drugs, immunotherapy, etc.) drug treatment therapies, and entomology solutions for infectious diseases of military relevance; and/or other medical countermeasures, and/or regenerative medicine; and/or blood and blood products/components and other combat casualty care products or devices; 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. Activities include but are not limited to: serving 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 Project Manager (PjM)/Product Manager (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.
- Shall orchestrate the requisite regulatory strategy as well as organization and compliance activities as contained in USAMRDC regulations, policies, pamphlets, and SOP Interact with USAMMDA, USAMRDC, and other Government Agencies to assist in identifying, interpreting, prioritizing, and analyzing FDA, CFR, DoD, DA, USAMRDC 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 that 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.
- 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 devices, pharmaceuticals, and vaccines.
- 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)
- Assess CMC related risk of commercial partners.
- Perform audits and provide GMP compliance advice.
- Shall 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 and 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 that will be submitted to the FDA, EPA or other Governmental or Military organizations.
- Provide manuscript reviews for documents/reports submitted to scientific journals.
Qualifications:
Necessary Skills and Knowledge:
- Excellent communication skills both written and verbal.
- Leadership experience with ability to think critically and act with little direction and quickly.
- Ability to work well across multiple groups.
- Must be organized with strong attention to detail coupled with strong project management experience.
- Experience with MS Office including Word, Excel, PowerPoint, and Outlook required.
- Requires excellent communication, writing, organizational and project management skills.
- SharePoint and MS Project experience desired.
Minimum Qualifications:
- Bachelor’s Degree in a related field.
- At least five (5) years of experience in radiology/imaging, biomedical engineering, science/technology, or another related technical field.
- Two (2) to three (3) years of experience in Federal contracting, military environment preferred.
- Certifications: Active PMP certification
- Must be able to obtain and maintain a NACI Clearance.
- Must be a US citizen.
Preferred Qualifications:
- Master’s Degree in Science
- Certifications: Any related training or certifications desirable
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