Lead Safety & Regulatory Medical Writer (Pharmaceutical, Remote)

Job summary

This role involves leading the creation and delivery of Safety and Regulatory Medical Writing documents, with a strong emphasis on aggregate safety reports. The position serves as the main contact for safety writing projects, ensuring that all deliverables meet high-quality standards and comply with global regulatory requirements within set timelines.

Qualifications

• Bachelor’s degree in Life Sciences; Master’s or PhD preferred.
• Over 5 years of experience in Medical Writing, particularly in Safety Medical Writing.
• Proven experience in authoring DSURs, PSURs/PBRERs, and aggregate safety reports.
• In-depth knowledge of drug development, pharmacovigilance, and regulatory guidelines.
• Strong ability to interpret clinical and statistical data for regulatory submissions.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple projects simultaneously.

Responsibilities

• Serve as the lead author for Safety & Regulatory documents, including DSURs, PSURs/PBRERs, and other aggregate safety reports.
• Ensure compliance with global regulations (ICH, EMA, FDA) and client standards.
• Integrate clinical, safety, and statistical data into coherent regulatory narratives.
• Manage document timelines, oversee reviews, and address client comments.
• Conduct senior reviews of safety and regulatory deliverables.
• Collaborate with cross-functional teams and maintain direct communication with clients.
• Assist in project planning, forecasting, and budget tracking as necessary.
• Mentor junior writers and contribute to training initiatives.