Medical Writer – Regulatory Documents

Responsibilities

• Author clinical study reports (CSRs), investigator brochures, and CTD Module 2 summaries.
• Write and review clinical overview, clinical summary, and nonclinical written summaries.
• Ensure consistency and quality of medical writing across regulatory submissions.
• Collaborate with clinical, biostatistics, and regulatory teams on document strategy.
• Manage medical writing timelines and coordinate with external writing vendors.

Requirements

• PhD or Master's in Life Sciences, Medicine, or Pharmacy.
• 4-7 years of medical writing experience in the pharmaceutical industry.
• Extensive experience with ICH CTD format and regulatory submission documents.
• Strong command of scientific English with excellent writing and editing skills.
• Knowledge of AMWA/EMWA medical writing guidelines.