Product Management Support - Blood Subject Matter Expert Support

Bering-Alaka`ina Holdings, LLC is looking for has a potential need for a Product Management Support - Blood Subject Matter Expert Support to provide support for our government customer in Frederick, MD at Fort Detrick Army Base. DESCRIPTION OF RESPONSIBILITIES: Serve as Blood and Blood Product Development/Combat Casualty Care Research Technical Advisor/Subject Matter Expert (SME) Serve as an advisor and subject matter expert (SME) in Blood and Blood Products, Blood Research, Blood Product Operations, and other Combat Casualty Care Products or Devices to include traumatic hemorrhage, hematology, and transfusion medicine. Provide proactive, top level technical expertise to the PMO and support the advanced development requirements for medical products, requiring the ability to manage numerous efforts and effectively prioritize and multi-task initiatives and projects. Independently perform activities consistent with established organizational practices, precedents, policies and strategic objectives set forth by PMO leadership and freely communicate the status of those activities to assigned PdMs and PMO Leadership. Work closely with the advanced development team to facilitate development design sessions of major product initiatives and associated activities throughout the entire lifecycle of the assigned products. Maintain current knowledge of relevant technology and industry developments through independent market research, stakeholder engagement, and continuing education. Act as integral member of Integrated Product Teams (IPT), preparing for, attending, and contributing to internal and external meetings such as working groups, committees and subcommittees, one-on-one or small group touchpoints, site visits, program briefings, investigator meetings, and partner update meetings. Successfully communicate with personnel at various echelons using effective interpersonal and communication skills, both written and oral. Assess and monitor the risks and stakeholder positions/opinions associated with development of blood and blood products and communicate findings to the PdM and/or PMO Leadership. Support PdMs with program document preparation throughout the DoD Acquisition Lifecycle to include Acquisition Strategies, Acquisition Decision Memoranda, Acquisition Program Baselines, Analysis of Alternatives, Requirements Documents, Concepts of Operations/Use/Employment, Life Cycle Sustainment Plans, Life Cycle Cost Estimates, Requests for Information/Proposal, Systems Engineering Plans, and Test and Evaluation Master Plans. Provide expertise and assist PdMs with writing program documentation such as information/position/white papers, RFI responses, memoranda for program record, publications, technical guides, executive summaries and situational reports, data summaries, market research reports, risk assessments, program-relevant plans and protocols, decision logs, and briefings. Review program documentation for technical correctness and give expert analysis on highly specialized tasks including design and evaluation of non-clinical studies. Provide development and execution of clinical trial designs; review of non-clinical study reports; inputs into the chemistry, manufacturing and controls of biologics, drugs and devices; development of plans for testing, fielding, delivery, and/or training on assigned products. Development and implementation of policies, regulations, or other documentation that governs how blood products and combat casualty care-related products will be acquired, used, and tracked. Proactively review clinical protocols and associated clinical trial documents, various regulatory applications and communications, and Food and Drug Administration (FDA) recommendations. Extensive travel up to 30 percent of the time. Other duties as assigned by Supervisor. REQUIRED DEGREE/EDUCATION/CERTIFICATION: Must hold minimum of Bachelor's degree. REQUIRED SKILLS AND EXPERIENCE: Must have minimum of six to eight (6-8) years' of relevant experience. 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 be able to pass a Tier 1 Background Investigation for position of Public Trust. This posting is a pooling requisition only for a position(s) associated with a proposal for a Government contract. A hiring action will not be made from this requisition, and salary information is not available. Bering-Alaka`ina Holdings, LLC is a fast-growing government service provider. Employees enjoy competitive salaries. 401K plan with company match medical, dental, disability, and life insurance coverage tuition reimbursement paid time off 11 paid holidays We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We not illegally discriminate in employment decisions on the basis of any protected categories. We E-Verify all employees. As a part of BSNC, Bering- Alakaina Holdings gives hiring, promotion, training, and retention preference to BSNC shareholders, descendants and shareholder spouses who meet the minimum qualifications for the job. Qualified job candidates will generally be considered in the following order: BSNC shareholders, descendants, shareholder spouses, current employees, and outside candidates. The BSNC Shareholder Development department tracks and monitors the implementation of the Shareholder Hire Preference across its operations. Bering-Alaka`ina Holdings, LLC is comprised of industry-recognized government service firms designated as Alaska Native Corporation (ACN)-owned and 8(a) certified businesses and includes Ke`aki Technologies, LLC; Laulima Government Solutions, LLC; Kpono Government Services, LLC; Kapili Services, LLC; Po`okela Solutions, LLC; Kkaha Solutions, LLC; and Pololei Solutions, LLC. For additional information, please visit #LI-JS1 #ClearanceJobs #J-18808-Ljbffr