Senior Product Management Support Specialist

Overview

LMI is seeking an experienced Senior Product Management Support Specialist to support our DoD customer (USAMMDA) with the advanced development, fielding, maintenance and sustainment of military medical equipment. This hybrid position (partial onsite, partial remote work) supports our client at Fort Detrick, MD and our LMI office is within 10 miles of Fort Detrick. 

LMI is a private government consulting firm, dedicated exclusively to advancing the management of the government. Founded in 1961, we deliver the best value for the government dollar as all revenues are directed to our mission of advancing government rather than to delivering shareholder value. We operate completely free of political and commercial bias, and we are entirely aligned with the goals of our clients. Our clients value our Specialized services in logistics, intelligence, homeland security, healthcare, and energy and environment markets. We believe government can make a difference, and we seek talented, hardworking people who share that conviction. 

LMI offers a generous compensation package with excellent benefits that start the first day of employment. Business casual dress, flex time, and tuition reimbursement are a few of our many work-life benefits available to our employees. 

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.

Responsibilities

Organization Wide Support 

• 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.  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. 
• Develop and improve USAMMDA’s processes for acquisition planning, milestone and documentation preparation, and reporting. Support development of templates, Standard Operating Procedures, and checklists for acquisition processes. 
• Conduct analysis of policy and guidance to identify impacts and opportunities related to USAMMDA’s acquisition programs.   
• 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. 

Program Support

• 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.   
• 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, considering elements such as reliability, maintainability, availability, and cybersecurity (Risk Management Framework). 
• Support the development of technology transition strategies, integrated risk assessments, and tailored acquisition strategies, program briefings, integrating the unique aspects of medical product development with the DoD acquisition processes.   
• Employ effective risk management practices in support of the program acquisition strategy.   
• Coordinate and conduct site visits (e.g. clinical, vendors, testing facilities, manufacturing facilities).   
• 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.   

Internal Project Management

• Communicate and coordinate with internal and external stakeholders to meet program objectives and shall document their coordination; including the achievement of concurrence and/or non-concurrence with comment as directed by USAMMDA.   
• Assist in coordinating any needed support agreements with extramural customers, DoD stakeholders, or commercial entities.   
• Populate and maintain tracking of action items/taskers for specified product development programs according to DoD, Army, USAMRDC, and USAMMDA policies and procedures.   
• Monitor, coordinate, and report responses to external requests and tasks for information, ensuring responses are timely and accurate. 
• Follow established industry best practices to determine the effectiveness of current operational activities and to determine problem areas and develop solutions.     
• Manage the electronic filing, maintenance, and recovery of all program documentation on existing electronic records management systems.   
• 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.   

Test and Evaluation

• Provide support for all testing as well as all FDA and non-FDA regulated events.  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. 
• 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. 

Technology Assessment

• 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.   
• Participate in task forces and surveys, studies, and other investigations of areas of management operations to determine adequacy of medical equipment.   
• Support the management and execution of product evaluations and responses for the New Products and Ideas submissions.   
• 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. 

Force Health Protection (FHP) Support

• Provide Program/Project Management Support to the USAMMDA Organization within the realm of the FHP mission space.  
• Apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for FHP missions.   
• 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 shall be written, web-based, electronic, and other easily exportable forms of instruction and meet requirements for Graduate Medical Education approval.  
• Provide training on IND products, man-made threats, and endemic diseases.  The training shall cover therapeutic use of the IND products and will be presented to appropriate DoD medical personnel in domestic and overseas locations.   
• 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.   
• 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. 
• Provide storage, protocol management, and product issue for FHP IND products entrusted to their care.   
• Provide internal consulting capability in addition to the performance of PjM duties for a variety of investigational FDA regulated products in the FHP portfolio.  
• Support the writing, coordination, and submission of required annual reports to the FDA and continuing review reports to the IRB of Record.   

Qualifications

• Master`s degree required.
• Minimum 10 years  relevant work experience in the areas referenced above.
• Ability to obtain NACI (background investigation).
• Seven (7) years of experience with medical product development, DoD T&E requirements, and regulatory approval processes is preferred.
• Apply interpersonal skills and knowledge of the DoD 5000 to products being supported.   
• Integrating the DoD acquisition processes with the FDA regulatory processes and the Environmental Protection Agency (EPA) process.  
• Expert level knowledge of Joint Capabilities Integration and Development System (JCIDS); PPBE; and DoD 5000 processes, including adaptive acquisition framework pathways, to support strategic analysis and acquisition planning for Army and DHA ACAT designated medical programs.   
• Utilize MS Office, to include MS Outlook, MS Project, MS PowerPoint, MS Excel, and MS Word, at an intermediate level. 

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