Are you a seasoned medical writing professional with a passion for innovation and a drive to make a difference in the healthcare industry? Pharmabharat.org is excited to announce a fantastic opportunity for a Principal Medical Writer to join a globally renowned organization in Bangalore, Karnataka, India. If you have over 10 years of experience in the pharma industry and a strong background in regulatory medical writing, this could be the perfect role for you!
About the Role
As a Principal Medical Writer, you will play a critical role in leading medical writing efforts for marketed products and lifecycle management. This position offers the chance to work on a global scale, contributing to the development of life-changing medicines and technologies.
Key Responsibilities:
- Independently prepare and oversee the creation of clinical and regulatory documents, including Protocols, Clinical Study Reports, Investigator Brochures, and Clinical Summary Documents.
- Support submissions for market approval and line extensions with minimal supervision.
- Coordinate and oversee external writers, ensuring adherence to business objectives, company standards, and regulatory requirements.
- Represent the medical writing department as a subject-matter expert on clinical study teams, leading document-related meetings and reviewing study-related materials.
- Ensure all documents are produced on time, comply with SOPs, and meet the expectations of regulatory authorities.
- Contribute to the development and implementation of best practices and process improvements in medical writing.
Who We Are Looking For
To excel in this role, you should have:
- A graduate or postgraduate degree in BPharm/MPharm, PhD, BDS (Dental), BSc/MSc, or equivalent experience. An MD/PhD or advanced science degree is a plus.
- Over 10 years of experience in the pharma industry, with 5-8 years specifically in regulatory medical writing (including post-marketing studies).
- Excellent written and spoken English, with a strong grasp of medical terminology and familiarity with the AMA style guide.
- A proactive mindset, strong leadership skills, and the ability to work collaboratively in a global team.
How to Apply
If you’re ready to take the next step in your career and make a meaningful impact in the healthcare industry, we’d love to hear from you! Apply now to join our diverse and dynamic team.