Merck Healthcare
Merck Healthcare hiring Principal Medical Writer
Merck Healthcare, a global leader in science and technology, is looking for a Principal Medical Writer to join its team in Bangalore, Karnataka, India. This full-time opportunity is ideal for experienced professionals in regulatory medical writing, particularly those with expertise in post-marketing studies.
About Merck Healthcare
Merck Healthcare is dedicated to helping create, improve, and prolong lives. The company focuses on developing innovative medicines, intelligent devices, and cutting-edge technologies in therapeutic areas such as Oncology, Neurology, and Fertility. With a strong presence across six continents, Merck offers a collaborative and inclusive work culture that encourages professional growth and career advancement.
Principal Medical Writer
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Who you are:
- Graduate or post graduate degree in BPharm/MPharm, PHD, BDS (Dental), BSC/MSC or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
- > 10 years experience in Pharma Industry (with 5 to 8 years of experience in Regulatory medical writing, including experience in postmarketing studies)
- Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.
Responsibilities :
- As a Principal Medical Writer you will play a pivotal role in leading the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional/local levels.
- This includes independently preparing or overseeing the preparation of clinical and regulatory documents such as Protocols, Clinical Study Reports, Investigator Brochures, or Clinical Summary documents. You will also be responsible for supporting submissions for market approval/line extensions under minimal supervision.
- In this role, you will oversee and coordinate other (external) writers assisting on documents under your responsibility, ensuring strict adherence to business objectives, company standards, as well as the organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar.
- You will represent the department as a subject-matter expert on clinical study teams, leading document-related meetings and reviewing study-related documents.
- Additionally, you will ensure that all documents are produced according to agreed timelines, adhere to relevant SOPs, and meet the requirements of regulatory authorities and the company.
- Furthermore, you will play a proactive role in contributing to the development and implementation of Medical Writing best practices and process improvements.
