Senior Clinical Writing Director
5 hours ago
Unlock your career potential as a Senior Clinical Writing Director at Lifelancer.
About the RoleThis is a permanent position with flexible location options, including Ipsen UK or France, and remote working opportunities available. As a Senior Clinical Writing Director, you will lead medical writing activities for US, European, and other regulatory submissions.
The ideal candidate will have 7+ years' experience in pharmaceutical, biotech, academic, or CRO environments, with a proven track record of medical writing within a relevant therapy area.
Key Responsibilities- Establish strategies to drive clinical study and regulatory document authoring to highest quality and regulatory standards.
- Lead by example, serving as an expert document author and directing and supervising the authoring of documents within the framework of and in compliance with ICH-GCP, applicable regulatory guidelines, RD SOPs, and other Ipsen policies.
- Contribute to building capabilities and technical skills across the medical writing department.
- Graduate Degree (Masters or Doctorate preferred) in a relevant scientific discipline.
- In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Cross-cultural understanding and sensitivity.
- Managerial capability with proven leadership profile.
We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience.
Lifelancer provides a dynamic and supportive work environment, with opportunities for professional growth and development.
Additional benefits include a comprehensive health insurance plan, retirement savings plan, and generous paid time off.
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