Medical Advisor — Clinical Trials & Regulatory Strategy

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 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.