Role Overview
As a Senior Medical Writer at Pharmaleaf, you will play a central role in transforming complex statistical and clinical trial results into clear, concise, scientifically accurate, and regulatory-compliant documents. You will interface directly with clinical project teams, biostatisticians, and medical monitors to deliver critical regulatory assets.
Key Challenges & Impact
Core Challenge Solved
Distilling intricate biostatistical output (CDISC ADaM datasets) into audit-proof Clinical Study Reports (CSRs) under aggressive submission timelines.
Your work directly accelerates regulatory review processes, enabling life-saving therapies to reach approval faster without sacrificing scientific integrity or clarity.
Key Responsibilities
- Author Phase I-IV Clinical Study Reports (CSRs) in accordance with ICH E3 guidelines.
- Draft clinical trial protocols, protocol amendments, and Investigator's Brochures (IBs).
- Prepare patient safety narrative summaries for expedited and aggregate regulatory reporting.
- Collaborate with biostatisticians to interpret statistical analysis plans (SAPs) and summary tables/figures.
- Perform Quality Control (QC) review and data verification on clinical documents.
- Lead multi-disciplinary document review meetings, resolving author queries and consensus feedback.
Qualifications & Requirements
- PhD, PharmD, MD, or Master's degree in Life Sciences, Pharmacology, or Communication.
- 4+ years of dedicated regulatory medical writing experience within a pharmaceutical company or CRO.
- Expert mastery of ICH GCP guidelines, GVP requirements, and electronic submission templates.
- Demonstrated ability to write clear, concise scientific documents under tight deadlines.
- AMWA (American Medical Writers Association) or EMWA certification is highly desirable.