Senior Medical Writer Role:
- Lead a team of Content Strategists and cross-functional colleagues to build content strategy for global regulatory submissions.
- Plan timelines for producing and reviewing documents, keeping them aligned with wider project deadlines.
- Review documents for clarity, structure, and scientific accuracy.
- Act as a key voice in functional and cross-functional teams, helping shape best practice and drive improvements.
- Keep your knowledge sharp on regulatory, scientific, and medical developments relevant to the therapeutic area.
Your Background:
- Degree in Life Sciences or equivalent, with at least 5 years’ experience in pharma or biotech.
- Solid understanding of global drug and device development processes and regulations, including GxP, GCP, ICH, ISO, and MDR/IVDR.
- Strong background in clinical, safety, or device regulatory documentation across the full product lifecycle.
- Able to independently analyse and pull together clinical and non-clinical data from a range of disciplines.
- Skilled in G Suite, Microsoft Office, Adobe Acrobat, and Veeva Vault.
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