Location: Bangalore
Industry: Pharma/Healthcare/Clinical Research
Qualification: BPharm/MPharm, PhD, BDS (Dental), BSC/MSC or equivalent
Experience: 5-8 years
End Date for Applications: 30th January 2025
Merck is looking for a Principal Medical Writer to join their team. This position is focused on leading medical writing efforts for Marketed Products and Lifecycle Management, globally and regionally. The role involves preparing and overseeing clinical and regulatory documents such as Protocols, Clinical Study Reports, Investigator Brochures, and Clinical Summary documents. You will also be responsible for supporting market approval and line extensions under minimal supervision.
Key Responsibilities:
- Lead and manage the preparation of clinical and regulatory documents.
- Ensure adherence to business objectives, company standards, and English language accuracy.
- Coordinate with external writers and oversee document production.
- Contribute to the development of Medical Writing best practices and process improvements.
- Represent the department on clinical study teams and ensure timely document production.
Candidate Requirements:
- Graduate or post-graduate degree in BPharm/MPharm, PhD, BDS, BSC/MSC or equivalent experience.
- Over 10 years of experience in the pharma industry with 5-8 years in regulatory medical writing, including post-marketing studies.
- Excellent proficiency in written and spoken English, including medical terminology.
- Familiarity with AMA style guide.
