The job posting for the position of Senior Specialist / Expert Medical Writer at Merck offers an opportunity to work in a dynamic environment with a focus on market approval, lifecycle management, and clinical and regulatory documentation.
Key Responsibilities:
- Preparation of clinical and regulatory documents like Protocols, Clinical Study Reports, Investigator Brochures.
- Support submissions for market approval and line extensions under minimal supervision.
- Contribute to the development and implementation of Medical Writing best practices and process improvements.
- Oversee external writers, ensuring adherence to business objectives, standards, and the quality of content.
- Ensure compliance with timelines, SOPs, and regulatory requirements.
- Participate in meetings related to medical writing, quality control, and compliance activities.
Candidate Profile:
- Graduate/Post-graduate degree in BPharm, MPharm, PhD, BDS, BSc, MSc, or equivalent with comprehensive knowledge of medical writing.
- 4-9 years of regulatory medical writing experience.
- Excellent written and spoken English, with familiarity with AMA style guide.
- Solid understanding of clinical and regulatory documents.
Location:
- Bangalore, India.
Application Deadline:
- 30th January 2025.