About this opportunity
Alaka`ina Foundation Family of Companies lists this Medical Advisor Support Specialist opportunity in frederick, Maryland. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Medical Advisor Support Specialist
nLocation MD - Frederick
nJob Code 14439
nSalary Range
nof openings 1
nApply Now (
nBering-Alaka`ina Holdings, LLC is looking for has a potential need for a Medical Advisor Support Specialist to provide support for our government customer in Frederick, MD at Fort Detrick Army Base.
nDESCRIPTION OF RESPONSIBILITIES:
nnnProvide 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.
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nnProvide clinical management expertise for both DoD-sponsored and non-DoD-sponsored clinical research activities.
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nnServe 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.
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nnAssist in the writing and preparation of clinical protocols and other clinical trial documents; serve as a key member of IPT.
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nnProvide expertise to aid in the development of the research strategy for clinical trials.
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nnProvide subject matter expertise in clinical trial site selection, site set-up, and subject recruitment and retention.
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nnProvide 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.
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nnAttend and participate in site visits, IPT meetings and briefings, and sub-working group and investigator meetings.
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nnOrchestrate the requisite regulatory strategy as well as organization and compliance activities as contained in appropriate DOD and DHA regulations, policies, pamphlets, and SOP.
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nnInteract 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.
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nnCoordinate 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.
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nnCollaborate as necessary to identify regulatory affairs (RA) strategies will optimize product development.
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nnReview and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data.
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nnFacilitate an understanding of the requirements for compliance with all applicable FDA regulations.
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nnUnderstand 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.
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nnAssist 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.
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nnProvide professional medical review of Investigational Device Exemption, IND protocols, IND packages, and plans for management of IND products.
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nnProvide subject matter expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC).
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nnReview 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.
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nnAssess CMC related risk of commercial partners.
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nnPerform audits and provide GMP compliance advice.
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nnBe a substantive participant in IPTs as a SME.
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nnProvide expert written reviews, briefings, and recommendations for developmental medical projects to include reviewing and interpreting results.
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nnSupport scientific preparation of data analysis results for eventual publication in peer reviewed scientific journals or other media or publication.
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nnProvide a medical/expert review of documents to be submitted to the FDA, EPA or other Governmental or Military organizations.
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nnProvide manuscript reviews for documents/reports submitted to scientific journals.
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nnOther duties as assigned by Supervisor.
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n nREQUIRED DEGREE/EDUCATION/CERTIFICATION:
nnMust hold minimum of 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.
n nREQUIRED SKILLS AND EXPERIENCE:
nnnMust have minimum of four (4) years’ of relevant experience.
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nnMust 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.
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nnMust have expertise in the development of the research strategy for clinical trials.
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nnMust have expertise in clinical trial site selection, site set-up, and subject recruitment and retention.
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nnMust have expertise regarding site investigator selection and issues related to clinical trial staff training.
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nnMust have expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC).
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nnMust 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.
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n nREQUIRED CITIZENSHIP AND CLEARANCE:
nnnMust 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.
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nnMust be able to pass a Tier 1 Background Investigation for position of Public Trust.
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n nThis 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.
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nBering-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.
nWe 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.
nAs 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.
nBering-Alakaina Holdings, LLC is comprised of industry-recognized government service firms designated as Alaska Native Corporation (ACN)-owned and 8(a) certified businesses and includes Keaki Technologies, LLC; Laulima Government Solutions, LLC; Kūpono Government Services, LLC; Kapili Services, LLC; Po`okela Solutions, LLC; Kīkaha Solutions, LLC; and Pololei Solutions, LLC.
nFor additional information, please visit
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Worksite address
frederick, MD, 21701, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.