Role Overview:
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.
Key Responsibilities:
- Custom Response Drafting:
- 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.
- Cross-Functional Collaboration:
- Partner with Medical Directors, Pharmacovigilance/Safety, Biostatistics, Regulatory Affairs, and Legal teams to vet technical or off-label data queries.
- Compliance & Quality Control (QC):
- 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).
- Literature & Data Retrieval:
- Conduct systematic literature searches to locate high-level evidence supporting complex clinical or subpopulation queries (e.g., renal/hepatic impairment, drug-drug interactions).
Required Qualifications & Skills
- 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.
- Core Competencies:
- Exceptional scientific writing and editing skills with a sharp eye for clinical nuance.
- Deep understanding of pharmaceutical compliance, off-label communication rules (FDA/EMA/local codes), and fair-balance principles.
- Familiarity with medical content management systems (Veeva, Salesforce, or equivalent).
- Strong project management skills to turn around custom inquiries within strict Service Level Agreements (SLAs).
