Comw-0 Principal Medical Writer

2 weeks ago

Bengaluru Karnataka, India Merck Group Full time

Work Your Magic with us

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 mínimal 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.
- 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.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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