Medical Writing Manager – Clinical & Regulatory
Overview
Management-level medical writing role leading the development, coordination, and delivery of clinical and regulatory documents supporting integral R&D; programs.
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Key Responsibilities
- Lead planning, authoring, and review of key clinical & regulatory documents (e.g. protocols, IBs, CSRs, paediatric plans, HA responses, submission dossiers).
- Ensure scientific accuracy, consistency, and compliance with ICH, GCP, and global regulatory standards.
- Provide strategic input into document planning, submission strategy, and global regulatory timelines.
- Partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and external stakeholders.
- Review and quality-check internally and externally authored documents.
- Develop and maintain writing standards, templates, and SOPs.
- Mentor and guide medical writers to ensure high-quality output.
- Drive innovation through the implementation of AI medical writing tools, including governance and quality controls.
- Manage external medical writing vendors, ensuring performance, quality, and process compliance.
Required Background
- Advanced degree in Life Sciences (PhD, PharmD, MD, MSc, or equivalent).
- 8+ years’ experience in medical writing within pharma or biotech.
- Proven experience supporting global regulatory submissions.
- Strong knowledge of ICH, GCP, CTD, and international regulatory frameworks.
- Experience managing external vendors and outsourced activities.
- Fluent English.
Highly Desirable
- Hands-on exposure to AI in regulated document workflows.
- Strong strategic mindset, attention to detail, and ability to influence cross-functional teams. xsgfvud
- Experience with document management systems and structured authoring approaches.
If you’re interested in learning more, feel free to reach out or apply below: