Regulatory Medical Content Lead
2 days ago
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.
- 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.
$120,000 - $150,000 per annum.
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