Principal Regulatory Medical Writer

Summary

The job is a remote Medical Writing role in a Global Medical Writing Consultancy offering learning opportunities, partnership with senior professionals, and the ability to work on various projects. It requires 4+ years of regulatory medical writing experience, expertise in ICH guidelines, strong project management skills, and the ability to deliver high-quality documents under tight timelines. The job offers L&D funding, an annual performance-based bonus, WFH flexibility, and access to online training services.

Requirements

• 4+ years of regulatory medical writing experience in the biotech/pharma/Consultancy environment
• Extensive experience authoring regulatory documents for FDA and EMA submissions
• Expert knowledge of ICH guidelines and other regulations governing clinical trials
• Strong experience as Lead Writer on CTD's, CSR's or Clinical Protocols
• Ability to work independently and collaborate cross-functionally in fast-paced environment
• Strong project management skills and ability to deliver high quality documents under tight timelines

Benefits

• L&D funding for Conferences, networking and workshops
• Annual Performance-Based Bonus
• WFH and Remote working flexibility
• Access to online training services