Medical Advisor Support Specialist

Bering-Alaka'ina Holdings, LLC; Frederick (MD); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

401K plan with company match

Medical, dental, disability and life保险

Tuition reimbursement

Paid time off

11 paid holidays

Job summary

Bering-Alaka`ina Holdings, LLC is seeking a Medical Advisor Support Specialist to support a government client at Fort Detrick, Frederick, MD. The role covers medical devices, diagnostics, drugs and biologics, with expertise in clinical trial planning and regulatory compliance.

Responsibilities include developing clinical protocols, coordinating trial activities, assisting in regulatory submissions, and guiding site selection and staff training.

Qualifications

• Must have at least four years of relevant experience.
• Expertise in medical devices, diagnostics, drugs, biologics or other medical countermeasures.
• Experience developing research strategies for clinical trials.
• Experience in site selection, site setup, and recruitment/retention.
• Familiarity with pharmaceutical quality/CMC and regulatory documents.

Responsibilities

• Provide SME guidance on clinical trial planning, design, and protocols.
• Support regulatory strategy and FDA/DoD guidance interpretation.
• Assist in regulatory submissions and trial documents.
• Coordinate with teams for site selection, training, and patient recruitment.
• Contribute to Integrated Master Plan/IMS for regulatory and clinical activities.

Skills

Clinical research expertise

Site management

CMC proficiency

DoD acquisition knowledge

Regulatory affairs

Education

Medical degree

Job description

Bering-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.

DESCRIPTION OF RESPONSIBILITIES

• 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 in 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 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 data analysis results 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 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.

REQUIRED SKILLS AND EXPERIENCE

• Must have minimum of four (4) years’ of relevant experience.
• 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 in the development of the research strategy for clinical trials.
• Must have expertise in clinical trial site selection, site set-up, and subject recruitment and retention.
• Must have expertise regarding site investigator selection and issues related to clinical trial staff training.
• Must have expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC).
• 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.

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.

Employees enjoy competitive salaries.

• 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.

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.

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