Force Health Protection (FHP) Senior Product Management Support Consultant

Kapili Services, LLC; Frederick (MD); On-site; USD 120,000 - 170,000; Full time

Job summary

Bering-Alaka`ina Holdings, LLC is seeking a senior consultant to provide Force Health Protection program management support for a government contract at Fort Detrick, MD. The role involves regulatory coordination, training, and documentation to support IND products and FDA pathways.

The candidate will interact with DoD medical staff and DHA, preparing technical reports and coordinating with IRBs while ensuring compliance with federal regulations. Domestic and international travel may be required.

Qualifications

• 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.
• Must be willing and able to obtain country/region specific vaccines/immunizations for international travel as needed.
• Must have capability to apply knowledge of DoD acquisition, force health protection, and regulatory product development.
• Must understand cGCP, cGLP and cGMP and CFR 21 for IND protocols.

Responsibilities

• Provide Force Health Protection (FHP) Program/Project Management Support.
• Develop necessary regulatory documentation and provide annual and refresher GCP training to medical staff.
• Provide training on IND products and regulatory pathways for DoD personnel.
• Coordinate with IPT and working groups; gather and analyze complex information for therapeutics, diagnostics, and clinical protocols.
• Review technical documents and ensure regulatory requirements are met for investigational products.

Skills

DoD acquisitions knowledge

cGCP/cGLP/cGMP

Regulatory documentation

IRB coordination

Education

Medical degree or higher

Job description

Bering-Alaka`ina Holdings, LLC is looking for has a potential need for a Force Health Protection (FHP) Senior Product Management Support Consultant 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.
• 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.
• 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 have the capability of applying knowledge in the area of DoD acquisition, force health protection, and clinical/ FDA regulatory product development.
• Must 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 21 Code of Federal Regulations (CFR) regulations concerning IND protocols.
• 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.
• Clinical Research Coordinator experience preferred.

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.

• 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; Kpono Government Services, LLC; Kapili Services, LLC; Po`okela Solutions, LLC; Kkaha Solutions, LLC; and Pololei Solutions, LLC.

For additional information, please visit www.beringalakaina.com

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