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Senior Medical Writing Expert
2 weeks ago
Pharma IT is seeking a seasoned Senior/Principal Medical Writing Consultant to join our Regulatory Affairs & Medical Writing Team.
The ideal candidate will have extensive experience in medical writing, with a strong understanding of international regulations and ICH guidelines.
You will work as a consultant to support clients in the Pharma, Biotech, and Medical Device industries, providing expert-level medical writing services.
We encourage applicants from diverse backgrounds to apply, and we value individuality and creativity.
Key Responsibilities- Write and review clinical documents for regulatory submissions, including Module 2.5, 2.7, 2.4, and integrated summaries of efficacy/safety.
- Participate in answering questions from Health Authorities worldwide.
- Write and review scientific publications and presentations.
- Collaborate with cross-functional teams to ensure project goals and deliverables.
- 10+ years of experience in drug development within the pharma/biotech industry, with at least 5 years of experience in medical writing.
- Strong understanding of international regulations, ICH guidelines, and clinical development processes.
- Excellent interpersonal skills, with the ability to collaborate effectively with multidisciplinary teams.
