Senior Product Manager

Position Summary: Odyssey Systems has an exciting new opportunity for a Senior Product Manager supporting the U.
S.
Army Medical Materiel Development Activity (USAMMDA), a subordinate command under United States Army Medical Research and Development Command (USAMRDC) in Frederick, MD.
***Contingent upon contract award*** Responsibilities: Duties include, but not limited to: Program and Project Management Support – General Provide Program/Project Management Support to USAMMDA within the realm of the DoD’s acquisition process Apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for product development 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 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 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 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, development of these documents Consider elements such as reliability, maintainability, availability, and cybersecurity (Risk Management Framework) 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 Employ effective risk management practices in support of the program acquisition strategy 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 Use the USAMRDC electronic document management system (EDMS)/LiveLinksystems Manage the electronic filing, maintenance, and recovery of all program documentation on existing electronic records management systems Copy files from network servers to their corresponding location within Opentext Livelink and/or MS Sharepoint Provide support for all testing as well as all FDA and non-FDA regulated events Monnitor 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 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 Develop and updating schedules, as well as assist in the development of LCCEs Provide the capability of integrating the DoD acquisition processes with the FDA regulatory processes and the Environmental Protection Agency (EPA) process 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 Participate in IPT and working group meetings as required Coordinate with multiple stakeholders to gather and analyze technically complex information, project management of therapeutics, prophylactics, diagnostics, and management of clinical trials 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 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 Interact with SMEs, USAMRDC IRB, along with local reviewing IRBs, to gain IRB approval Provide storage, protocol management, and product issue for FHP IND products entrusted to their care Personnel performing in this task area shall 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 Research, develop, and write content for printed manuals, protocols, documentation, and supporting materials Prepare written documents following standard guidelines for technical publications Coordinate layout and organization of documentation, review, and revise previously created documentation and create graphical images, flow charts, and diagrams for inclusion in documentation Review, edit, and proofread materials written by others 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 shall 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.
FHP Contingency Protocol Support 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 Serve as an ad hoc and on site consultant when exigencies arise, often outside normal duty hours but requiring immediate attention Perform substantive analytical and alternatives analyses of forecasted and emergent requirements for contingency protocol support and interface with DoD partners regarding such forecasted or emergent requirements Personnel performing in this task area shall have the capability of using knowledge to develop and maintain interagency partnerships to ensure that regulatory, operational, and logistical requirements for each IND protocol are met Personnel performing in this task area shall have the capability of providing expertise in DoD garrison and deployment healthcare systems, management of new and ongoing clinical trials, pharmaceutical inventory, and GMP requirements for storage and testing Qualifications: Minimum Required Qualifications: Citizenship: Must be a US citizen Clearance: Ability to obtain NACI Education: Bachelors of Science discipline such as virology or microbiology Years’ experience: 10+ years experience in infectious diseases, bio-threats or molecular diagnostics Certifications: Working understanding of Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Current Good Manufacturing Practices (cGMP) Preferred Qualifications: Education: Masters in science discipline such as virology or microbiology Years’ experience: 10+ years experience in infectious diseases, bio-threats or molecular diagnostics Interpersonal Skills: Excellent communication skills Leadership experience with ability to think critically and act with little direction and quickly Ability to work well across multiple group Strong attention to detail Additional Information: Location: Onsite in Frederick, MD (local candidates only); Telework eligible Travel: 10% ***Contingent upon contract award*** #LI-AS1 Company Overview: Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients.
We focus on people, processes, and performance to deliver superior results.
Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings.
We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.
Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities