Force Health Protection (FHP) Senior Product Management Support

Bering-Alaka`ina Holdings, LLC is looking for has a potential need for a Force Health Protection (FHP) Senior Product Management Support Specialist to provide support for our government customer in Frederick, MD at Fort Detrick Army Base.

Travel to CONUS and OCONUS locations may be required.

DESCRIPTION OF RESPONSIBILITIES:

• Provide Force Health Protection (FHP) Program/Project Management Support.
• Work 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. 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 Investigational New Drugs (IND), including the use of the IND products and applicable regulatory pathways (e.g. Emergency Use Authorizations, Expanded Access protocols) and requirements, 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 protocols.
• Review and analyze technical documents and make recommendations to ensure sound scientific processes are used to support the portfolio of investigational products and 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 Division.
• Work with DHA Office of Regulated Activities for ensuring IND protocols meet all regulatory requirements, such as supporting submission of documents for FDA.
• Interact with SMEs, appropriate Institutional Review Boards (IRB), to gain IRB approval. The Contractor shall provide storage, protocol management, and oversee product release for FHP IND products entrusted to their care.
• 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 as appropriate.
• Provide expertise in the areas of medical devices, diagnostics, drugs and biologics, and/or other medical countermeasures; and/or blood and blood products/components and other medical solutions; and/or post-traumatic stress disorder and traumatic brain injury.
• Provide clinical management expertise for both DoD-sponsored and non-DoD-sponsored clinical research activities.
• Serve 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 PjM/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.
• Attend and participate in site visits, IPT meetings and briefings, and sub-working group and investigator meetings.
• Orchestrate the requisite regulatory strategy as well as organization and compliance activities as contained in appropriate DOD and DHA regulations, policies, pamphlets, and SOP.
• Interact with stakeholders to assist in identifying, interpreting, prioritizing, and analyzing FDA, CFR, DoD, and DHA policies, regulations, and guidance documents as they relate to products in different stages of development.
• 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.
• Collaborate as necessary to identify regulatory affairs (RA) strategies that will optimize product development.
• 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.
• 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.
• 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 medical devices, drugs, biologics, blood and blood products and or other medical solutions.
• Provide professional medical review of Investigational Device Exemption, IND protocols, IND packages, and plans for management of IND products.
• Provide subject matter expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC).
• Review technical documents (e.g., Master Production Records/Batch Production Records, testing protocols/reports, investigations, Corrective and Preventive Actions, etc.) and regulatory submissions (e.g., INDs, amendments, annual reports, protocols, IBs) as requested and provide feedback to the Product Manager.
• Assess CMC related risk of commercial partners, perform audits and provide GMP compliance advice
• Be a substantive participant in IPTs as a SME.
• Provide expert written reviews, briefings, and recommendations for developmental medical projects to include reviewing and interpreting results.
• Support scientific preparation of results of data analysis for eventual publication in peer reviewed scientific journals or other media or publication.
• Provide a medical/expert review of documents to be submitted to the FDA, EPA or other Governmental or Military organizations.
• Provide manuscript reviews for documents/reports submitted to scientific journals.
• Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

• Must possess a medical degree, doctorate, other advanced degree, or certification in a medical, scientific, or technical field related to the specific area of medical product development.

REQUIRED SKILLS AND EXPERIENCE:

• Must be willing and able to obtain country/region specific vaccines/immunizations required for international travel as needed.
• Must possess the expertise to interpret and synthesize information from new or changing DoD or Agency Directives, Instructions, and guidance documents to draft reports, briefings, and decision/information papers for review.
• Must have the capability of applying knowledge in the area of DoD acquisition, force health protection, and clinical/FDA regulatory product development.
• Must have the capability of applying knowledge of the DoD's acquisition process in conjunction with their expertise in performance of all tasks as stated above for the given clinical problem and relevant epidemiology.
• Must have expertise in the areas of medical devices, diagnostics, drugs and biologics, and/or other medical countermeasures; and/or blood and blood products/components and other medical solutions; and/or post-traumatic stress disorder and traumatic brain injury.
• Must have expertise to aid in the development of the research strategy for clinical trials.
• Must have subject matter expertise in clinical trial site selection, site set-up, and subject recruitment and retention.
• Must have subject matter expertise to PjM/PdM regarding site investigator selection and issues related to clinical trial staff training.
• Must have subject matter expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC).

REQUIRED CITIZENSHIP AND CLEARANCE:

• Must hold or be able to obtain and maintain an Active U.S. Passport.
• 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. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 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. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. 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; Kūpono Government Services, LLC; Kapili Services, LLC; Po`okela Solutions, LLC; Kīkaha Solutions, LLC; and Pololei Solutions, LLC.

For additional information, please visit www.beringalakaina.com

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