Senior Regulatory Medical Writer - Remote Contract

Apsida Life Science; Remote; GBP 45,000 - 65,000; Part time

Job summary

A leading life sciences consulting firm is looking for an Experienced Medical Writer to join their team. This fully remote role requires an advanced degree and at least 5 years of medical writing experience, particularly in regulatory documents and briefing books. You will lead the planning and finalization of CTD modules while collaborating across various teams. The position offers a balance between work and personal life and presents an opportunity to contribute significantly to regulatory submissions.

Benefits

Work-life balance

Qualifications

• 5+ years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
• Proven experience in writing briefing books for scientific advice meetings.
• Direct experience with authoring and compiling regulatory documents for CTD Modules 2, 4, and 5.

Responsibilities

• Lead the planning, authoring, editing, and finalization of CTD modules.
• Ensure regulatory documents adhere to current guidance and standards.
• Collaborate with multidisciplinary teams to source and integrate data.

Skills

Medical writing

Regulatory compliance

Cross-functional collaboration

Document management

Risk Management Plans

Education

Advanced degree (PhD, Pharm.D., M.D., or Master’s)

Job description

A leading life sciences consulting firm is looking for an Experienced Medical Writer to join their team. This fully remote role requires an advanced degree and at least 5 years of medical writing experience, particularly in regulatory documents and briefing books. You will lead the planning and finalization of CTD modules while collaborating across various teams. The position offers a balance between work and personal life and presents an opportunity to contribute significantly to regulatory submissions.