Scientific Writing Director

1 month ago


Uxbridge, United Kingdom Bristol Myers Squibb Full time
Transform Lives with Bristol Myers Squibb

At Bristol Myers Squibb, we're pushing the boundaries of what's possible in pharmaceutical development. Our team of experts is dedicated to creating life-changing treatments that transform the lives of patients worldwide.

Join Our Team of Regulatory Documentation Experts

We're seeking a highly skilled Scientific Writing Director to join our team. As a key member of our regulatory documentation team, you'll play a critical role in ensuring the accuracy and quality of our clinical and regulatory documents.

Key Responsibilities:
  • Author complex clinical documents, including protocols, CSRs, and CTD summary documents, for timely submission to health authorities worldwide.
  • Participate in document strategy sessions and lead teams to define content and organization for complex documents.
  • Comply with internal and external processes and guidelines while managing the review process and resolving issues with pertinent team members.
  • Review and edit documents as required, ensuring optimal communication between authoring and development teams.
  • Serve as a liaison for external documentation support and prepare specifications for the work.
Qualifications & Experience:
  • PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation experience.
  • Demonstrated strong writing skills in authoring and managing the production of clinical and regulatory documents.
  • Ability to analyze and interpret complex data from a broad range of scientific disciplines.
  • Thorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting major regulatory submissions.
  • Excellent organizational, communication, facilitation, and interpersonal skills in a cross-functional team.

We offer a dynamic and supportive work environment, opportunities for growth and development, and a competitive compensation package. If you're passionate about making a difference in the lives of patients and have the skills and experience to excel in this role, we encourage you to apply.



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