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Background.  USAMMDA is the largest Department of Defense's (DoD) medical materiel development activity designed to protect and preserve the lives of Warfighters.  USAMMDA develops, modernizes, procures, and fields new drugs, vaccines, medical devices and support equipment that enhances readiness, ensuring the provision of the highest quality medical care to the DoD and maximizing survival of medical casualties on the battlefield.Program and Project Management Support The Contractor will provide Program/Project Management Support to USAMMDA within the realm of the DoD’s acquisition process.  The Contractor will apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for product development.   The Contractor will support the organization in the day-to-day medical product development activities according to U.S. Army, USAMRDC, USAMMDA, and DoD acquisition policies and regulations.  The Contractor will participate in Integrated Product Team (IPT), Working Group, Product Lifecycle Review Committee (PLRC), and Investigator meetings; as well as other meetings that are part of the acquisition process including, but not limited to, In Process Reviews and Milestone Reviews. The Contractor will organize and prepare for meetings, schedule teleconferences, create and distribute agendas, create meeting minutes to include draft/final minutes, and deliver assessments in the form of information products including packages and briefings to the organization.  The Contractor will coordinate and conduct site visits (e.g. clinical, vendors, testing facilities, manufacturing facilities).  The Contractor will coordinate the conduct of developmental testing as well as support and coordinate operational assessment and testing, to include delivery of test items such as test articles and manuals.   The Contractor will prepare and maintain project management integrated master schedules, Gantt charts, and action item lists for assigned programs, based on input from the organization, outside consultants, and key USAMRDC staff according to project management best practices and DoD guidelines to monitor program progress.  The Contractor will edit and maintain technical, budget, programmatic, administrative, and acquisition milestone documentation, to include program briefings IAW applicable DoD 5000 series regulations to ensure successful decision reviews, such as Business Case Analysis (BCA), Strategy Plans, Integrated Program Summary, Life Cycle Cost Estimates (LCCEs), Test and Evaluation Master Plans (TEMPs), and operating and maintenance instructions.  In development of these documents the Contractor will consider elements such as reliability, maintainability, availability, and cybersecurity (Risk Management Framework). The Contractor will communicate and coordinate with internal and external stakeholders to meet program objectives and will document their coordination; including the achievement of concurrence and/or non-concurrence with comment as directed by USAMMDA.  The Contractor will assist in coordinating any needed support agreements with extramural customers, DoD stakeholders, or commercial entities.  The Contractor will populate and maintain tracking of action items/taskers for specified product development programs according to DoD, Army, USAMRDC, and USAMMDA policies and procedures.  The Contractor will monitor, coordinate, and report responses to external requests and tasks for information, ensuring responses are timely and accurate. The Contractor will follow established industry best practices to determine the effectiveness of current operational activities and to determine problem areas and develop solutions.  The Contractor will employ effective risk management practices in support of the program acquisition strategy.  The Contractor will support management of the progress of projects/products and provide recommendations on acquisition strategies, maturity and risk of technologies, assess capability gaps for the focus areas for further development and/or investment. The Contractor will use the USAMRDC electronic document management system (EDMS)/LiveLinksystems.  The Contractor will manage the electronic filing, maintenance, and recovery of all program documentation on existing electronic records management systems.  The Contractor will copy files from network servers to their corresponding location within Opentext Livelink and/or MS Sharepoint.   The Contractor will provide support for all testing as well as all FDA and non-FDA regulated events.  The Contractor will monitor the progress of clinical projects and provide recommendations on impact to acquisition strategies, maturity and risk of technologies, ability to address capability gaps for the focus areas for further development and/or investment.  The Contractor will support the clinical projects to ensure the Grants Officer Representative and/or COR has auditable clinical tracking and status reports and meets acquisition regulatory requirements. The Contractor will conduct market research, support analyses, review existing tech base programs, and recommend acquisition strategies to strengthen and engage medical requirements and/or medical capabilities in support of force health protection and provide information packages based on the results of these analyses.  The Contractor will participate in task forces and surveys, studies, and other investigations of areas of management operations to determine adequacy of medical equipment.  The Contractor will support the management and execution of product evaluations and responses for the New Products and Ideas submissions.   Personnel performing in this task area will have the ability to apply interpersonal skills and knowledge of the DoD 5000 to products being supported.  Personnel performing in this task area will have the capability to utilize MS Office, to include MS Outlook, MS Project, MS PowerPoint, MS Excel, and MS Word, at an intermediate level.  In addition, personnel performing in this task area will have the capability of developing and updating schedules, as well as assist in the development of LCCEs.     The Contractor will provide the capability of integrating the DoD acquisition processes with the FDA regulatory processes and the Environmental Protection Agency (EPA) process. It is desired that the Contractor provide the capability to apply DoD acquisition integration to specific developmental technologies including, vaccine technology and drug treatment therapies for infectious diseases of military relevance; and/or regenerative medicine; and/or blood and blood products and other combat casualty care products or devices; and/or post traumatic stress disorder and traumatic brain injury; and/or medical support system and evacuation products and/or systems; and/or clinical and regulatory support.  Force Protection Health The Contractor will provide Program/Project Management Support to the USAMMDA Organization within the realm of the FHP mission space.  The Contractor will apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for FHP missions.   The Contractor will work with the USAMRDC Office of Regulatory Activities (ORA) to develop necessary regulatory documentation, organize, and provide annual and refresher Good Clinical Practices (GCP) training to medical and laboratory staff that provide patient care and oversee product management and accountability for FHP products and protocols. GCP training will be written, web-based, electronic, and other easily exportable forms of instruction and meet requirements for Graduate Medical Education approval. The Contractor will also provide training on IND products, man-made threats, and endemic diseases.  The training will cover therapeutic use of the IND products and will be presented to appropriate DoD medical personnel in domestic and overseas locations.  The Contractor will participate in IPT and working group meetings as required. The Contractor will coordinate with multiple stakeholders to gather and analyze technically complex information, project management of therapeutics, prophylactics, diagnostics, and management of clinical trials.  The Contractor will review and analyze technical documents and make recommendations to ensure that sound scientific processes are used to support the portfolio of investigational products and that those processes and any deliverables meet all federal regulatory requirements for the use of investigational products. The Contractor will coordinate meetings, lead working groups, develop and/or edit meeting minutes, develop technical reports, and assist with other tasks and deliverables as required to provide support to the FHP Directorate.   The Contractor will work with USAMRDC ORA for ensuring IND protocols met all regulatory requirements, such as supporting submission of documents for FDA approval to gain FDA approval.  The Contractor will interact with SMEs, USAMRDC IRB, along with local reviewing IRBs, to gain IRB approval. The Contractor will provide storage, protocol management, and product issue for FHP IND products entrusted to their care.   Personnel performing in this task area will be capable of understanding Current Good Clinical Practice (cGCP), Current Good Laboratory Practices (cGLP) and Current Good Manufacturing Practices (cGMP), to apply knowledge of FDA requirements and procedures, especially Title 5 Code of Federal Regulations (CFR) regulations concerning IND protocols. The Contractor will research, develop, and write content for printed manuals, protocols, documentation, and supporting materials.  The Contractor will prepare written documents following standard guidelines for technical publications.  The Contractor will coordinate layout and organization of documentation, review, and revise previously created documentation and create graphical images, flow charts, and diagrams for inclusion in documentation.  The Contractor will review, edit, and proo materials written by others.  The Contractor will assist in coordinating strategic communications, press releases, or other noteworthy information with the USAMMDA and/or USAMRDC PAO, as appropriate. Personnel performing in this task area will have the capability of applying knowledge in the area of DoD acquisition, force health protection, and clinical/ FDA regulatory product development to vaccine technology and drug treatment therapies for infectious diseases of military relevance, and/or chemical and biological defense medical countermeasures, and/or regenerative medicine and/or blood and blood products and other combat casualty care products or devices and/or post-traumatic stress disorder and traumatic brain injury and/or clinical and regulatory support. Travel to CONUS and OCONUS locations may be required. Medical and Technical Advisor SupportThe Contractor will 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. The Contractor will 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.  The Contractor will attend and participate in site visits, IPT meetings and briefings, and sub-working group and investigator meetings. The Contractor will orchestrate the requisite regulatory strategy as well as organization and compliance activities as contained in USAMRDC regulations, policies, pamphlets, and SOP. The Contractor will 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.  The Contractor will 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.  The Contractor will collaborate as necessary to identify regulatory affairs (RA) strategies that will optimize product development.  The Contractor will 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.  The Contractor will 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.  The Contractor will 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.  The Contractor will provide professional medical review of Investigational Device Exemption, IND protocols, IND packages, and plans for management of IND products. The Contractor will provide subject matter expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC).  The Contractor will assess CMC related risk of commercial partners.  The Contractor will perform audits and provide GMP compliance advice. The Contractor will be a substantive participant in IPTs as a SME.  The Contractor will provide expert written reviews, briefings, and recommendations for developmental medical projects to include reviewing and interpreting results.  At the end of data analysis, the Contractor will support scientific preparation of results for eventual publication in peer reviewed scientific journals or other media or publication.  The Contractor will provide a medical/expert review of documents that will be submitted to the FDA, EPA or other Governmental or Military organizations.  The Contractor will provide manuscript reviews for documents/reports submitted to scientific journals.