Lead Safety & Regulatory Medical Writer

Role Overview

Responsible for leading the authoring and delivery of Safety and Regulatory Medical Writing documents, with a strong focus on aggregate safety reports. Acts as the primary point of contact for safety writing projects, ensuring high‑quality, compliant deliverables aligned with global regulatory requirements and client timelines.

Key Responsibilities

• Lead author for Safety & Regulatory documents, including:
– DSURs
– PSURs / PBRERs
– Other aggregate safety and regulatory reports

• Ensure compliance with global regulations (ICH, EMA, FDA) and client standards.

• Integrate clinical, safety, and statistical data into clear and consistent regulatory narratives.

• Manage document timelines, reviews, and resolution of client comments.

• Perform senior review of safety and regulatory deliverables.

• Collaborate with cross‑functional teams and communicate directly with clients.

• Support project planning, forecasting, and budget tracking as required.

• Mentor junior writers and contribute to training initiatives.

Qualifications & Experience

• Bachelor’s degree in Life Sciences (Master’s or PhD preferred).

• 5+ years of Medical Writing experience, including significant Safety Medical Writing responsibility.

• Demonstrated hands‑on experience authoring DSURs, PSURs/PBRERs, and aggregate safety reports.

• Strong knowledge of drug development, pharmacovigilance, and regulatory guidelines.

• Ability to interpret clinical and statistical data for regulatory submissions.

• Excellent written and verbal communication skills.

• Strong organizational skills and ability to manage multiple projects.