Senior Product Management Support (Team Lead) WRPBH
Alakaina Family of Companies
Senior Product Management Support (Team Lead) Warfighter Readiness Performance and Brain Health (WRPBH)Bering-Alaka`ina Holdings, LLC is looking for a Senior Product Management Support (Team Lead) Warfighter Readiness Performance and Brain Health (WRPBH) to provide support for our government customer in Frederick, MD at Fort Detrick Army Base.Description of Responsibilities:Support the organization in the day-to-day medical product development activities according to DoD and acquisition policies and regulations.Participate in meetings central to defense acquisition program/project management including but not limited to: Integrated Product Team (s) (IPT), Working Group (s), and Product Manager/Vendor meetings; as well as other meetings part of the acquisition process including, but not limited to, In Process Reviews (IPRs) and Milestone Decision Reviews (MDRs).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 site visits (e.g. clinical, vendors, testing facilities, manufacturing facilities).Support the coordination of 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.Populate and maintain tracking of action items/taskers for specified product development programs according to DoD and DHA policies and procedures.Monitor, coordinate, and report responses to external requests and tasks for information, ensuring responses are timely and accurate.Utilize the electronic document management systems that maintain and transmit program documentation and records; managing the electronic filing, maintenance, and recovery of all program documentation on existing electronic records management systems.Support the conduct of market research, support analyses, and review of existing tech base programs.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 external inquiries.Produce draft reports, briefings, and decision/information papers identifying impacts, risks and opportunities for PMO review.Access classified information, classified spaces, and attend classified briefings at the SECRET level.Provide Program Management Support within the realm of the DoD's acquisition process by applying knowledge related to Federal regulations, policies and procedures to requirements involving the major issues and goals and objectives for product development. At a minimum, Federal Regulations include the DoDI 5000, FDA regulatory statutes, and Service-specific policies.Lead and/or participate in meetings central to defense acquisition program/project management including but not limited to: Integrated Product Team(s) (IPT), Working Group(s), and Product Manager/Vendor meetings, as well as other meetings part of the acquisition process including, but not limited to, In Process Reviews (IPRs) and Milestone Decision Reviews (MDRs).Coordinate and conduct site visits (e.g., clinical, vendors, testing facilities, and manufacturing facilities) and shall coordinate the conduct of developmental testing and operational assessment and testing, to include delivery of test items such as test articles and manuals.Prepare and maintain project management documents for assigned programs (e.g., integrated master schedules (IMS)/Gantt charts; stakeholder communication plans; risk analysis and management logs; change/decision logs, memos for program record; responses to requests for information; situational reports, executive summaries, information/position/white papers etc.) IAW project management best practices and DoD acquisition guidelines.Develop and maintain technical, budgetary, programmatic, administrative, and acquisition milestone documentation, to include program briefings IAW applicable DoDI 5000 series regulations to ensure successful decision reviews, such as Business Case Analyses (BCA), Strategy Plans, Simplified Acquisition Management Plans (SAMPs), Acquisition Decision Memoranda, Life Cycle Cost Estimates (LCCEs), Test and Evaluation Master Plans (TEMPs), Risk Management registers, and other documentation as needed to support the development effort of assigned programs.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 comments.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 and DHA policies and procedures.Monitor, coordinate, and report responses to external requests and tasks for information, ensuring responses are timely and accurate.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.Utilize the designated electronic document management systems that maintain and transmit program documentation and records; manage the electronic filing, maintenance, and recovery of all program documentation on existing electronic records management systems.Provide support for all relevant testing, to include all FDA and non-FDA regulated activities and events.Monitor the progress of acquisition program activities 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 acquisition program to ensure the COR has auditable COR file and acquisition program documentation that meets acquisition and 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 external inquiries.Other duties as assigned by Supervisor.Required Degree/Education/Certification:Must hold minimum of Bachelor's DegreeRequired Skills and Experience:Must have minimum of ten (10) years' of relevant experience.Must possess working knowledge of the DoD capability requirements development process, the DoDI 5000 systems acquisition process, DoD Planning, Programming, Budget and Execution (PPBE) system, and organizational acquisition policies.Must be capable of integrating the DoD acquisition processes with the FDA regulatory processes and the Environmental Protection Agency (EPA) process as required per product classification, including drugs, biologics, blood and blood products, medical devices, and other regulated medical solutions.Must possess the expertise to interpret and synthesize information from new or changing DoD or Agency Directives, Instructions, and guidance documents.Must be capable of operating independently to support the organization in the day-to-day medical product development activities according to DoD and DHA acquisition policies and regulations.Must have the ability to apply interpersonal skills and knowledge of the DoDI 5000 to assigned products.Must have proficiency, training and experience in Defense Acquisition Systems.Must have the capability of developing and updating schedules, as well as assist in the development of LCCEs.Required Citizenship and Clearance:Must be a U.S. Citizen, born or naturalized; for the purposes of this work Visa and GreenCard holders do not qualify and will not be considered.Must possess an Active Secret Clearance, or be able to pass a Tier 3 Background Investigation with Eligibility of Secret Clearance with Interim Status before start.
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