Head of Medical Writing
vor 3 Wochen
As a key member of our clinical team, you will be responsible for establishing medical and regulatory writing best practices to ensure consistency and quality of documents. Your expertise will be crucial in leading a writing team to generate key documents on schedule and supporting key documents in our partnerships with relevant functions.
Key Responsibilities- Develop and implement medical and regulatory writing best practices, including templates, SOPs, and work instructions.
- Lead a writing team to ensure timely generation of key documents, including clinical study protocols, clinical study reports, and regulatory submissions.
- Strategically complete key documents, such as responses to information requests from regulatory agencies and major regulatory submissions.
- Coordinate document writing, review, and revision to ensure high-quality documents that align with program strategy and objectives.
- Proactively plan future deliverables to ensure organizational alignment and preparation for document reviews.
- Oversight of medical and regulatory writing vendors in alignment with global internal resources, methods, and SOPs.
This is an autonomous area of responsibility with active participation in an international clinical team. You will have the opportunity to receive intensive training and mentoring. Our diverse benefits package includes mobile working, bike leasing, and a company pension.
We are a dynamic and innovative company that values the strengths of each employee. If you are a motivated and experienced medical writer looking for a new challenge, we encourage you to apply.
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