Senior Clinical Writing Director

5 hours ago


London, Greater London, United Kingdom Lifelancer Full time

Unlock your career potential as a Senior Clinical Writing Director at Lifelancer.

About the Role

This 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.
Requirements
  • 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.
Salary and Benefits

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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