[Hiring] Medical Affair Specialist @Soterius

Role Description

Responsible for researching, drafting, customizing, and peer-reviewing evidence-based medical and scientific response letters. This role ensures that unsolicited medical inquiries from healthcare professionals (HCPs) or health authorities are answered accurately, balanced fairly, and compliant with local regulatory and company-approved guidelines.

Qualifications

• Advanced degree in life sciences or health professions preferred (PharmD, PhD, MD, or MSc).
• 2–5 years of experience in Medical Affairs, Medical Information, or Medical Communications within the pharmaceutical, biotech, or medical device industry.

Requirements

• Synthesize clinical trial data, real-world evidence (RWE), pharmacovigilance reports, and peer-reviewed literature to answer complex, non-standard (custom) medical inquiries.
• Apply the “lead-with-the-data” principle to directly address the HCP’s core question upfront before detailing study methodology.
• Partner with Medical Directors, Pharmacovigilance/Safety, Biostatistics, Regulatory Affairs, and Legal teams to vet technical or off-label data queries.
• Ensure all custom letters remain scientifically balanced, non-promotional, and strictly aligned with approved product labeling (SmPC / USPI) and standard response documents (SRDs).
• Manage version control, reference verification (PubMed/DOIs), and audit-ready documentation in medical inquiry databases (e.g., Veeva Vault MedComms).
• Conduct systematic literature searches to locate high-level evidence supporting complex clinical or subpopulation queries (e.g., renal/hepatic impairment, drug-drug interactions).

Company Description