Regulatory Medical Content Lead

2 days ago


Liverpool, Liverpool, United Kingdom Life Sciences Recruitment Full time
Job Title:

Regulatory Medical Content Lead

About the Role:

We are seeking a highly skilled Regulatory Medical Content Lead to join our team at Life Sciences Recruitment. As a key member of our client's authoring team, you will be responsible for leading the preparation of clinical regulatory documents, ensuring timely delivery, and managing project budgets.

Key Responsibilities:
  • Prepare high-quality clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs) as the lead writer.
  • Collaborate with clients and internal stakeholders to ensure document quality and meet agreed timelines.
  • Manage project budgets, monitor expenses, and maintain accurate records.
  • Provide expert advice on document-specific requirements to clients.
  • Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
  • Project manage timelines and review cycles of your documents.
Requirements:
  • A minimum of 3 years of experience actively writing regulatory documents.
  • Proven track record as a lead writer on complex projects, with >3 senior medical writer or >5 principal medical writer-level projects.
  • Degree in science/pharmacy (Ph.D. not necessary).
  • Excellent written and spoken English skills.
  • An appreciation for well-written documents and attention to detail.
  • Strong interpersonal skills and ability to work collaboratively in a diverse team environment.
  • Flexibility and ability to stay focused under tight deadlines.
Salary:

$120,000 - $150,000 per annum.



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