AL Solutions is hiring a
Principal Regulatory Medical Writer, Remote - Italian Republic
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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
This job is filled or no longer available
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