Require Regulatory Medical Writer at Roche

Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

Post : Regulatory Medical Writer

The Position
In your capacity as a Regulatory Medical Writer, you will focus on crafting compliant medical documents that meet the rigorous standards of health authorities and regulatory bodies. You will also be responsible for maintaining a strong knowledge of medical terminology, guidelines, and regulations to ensure the accuracy and quality of all content produced. In addition, you must stay up to date on industry trends and best practices in medical writing and content creation, continuously improving and evolving our strategies to meet the changing needs of our partners. Your expertise and dedication to producing high-quality content will help us deliver impactful and relevant materials that resonate with our target audiences and drive success for the organization.

Job Description
• Writing and editing layperson clinical trial descriptions (lay CTD) and layperson summaries of clinical trial results (LPS), with the possibility of involvement in writing and editing CSRs, IBs, and Q&A documents.
• Ensuring that the content, format, and structure comply with regulatory and other guidelines, as well as with Roche's best practices
• Attending meetings and collating the key points from the conversations
• Exercising excellent interpersonal communication skills to effectively and professionally liaise with the internal teams, healthcare professionals, and other key stakeholders
• Proactively contributing with creative ideas, concepts, or suggestions to provide added value
• Working cross-functionally with global teams and pharma affiliates to develop various project deliverables
• Take ownership of project kickoffs and manage stakeholder expectations
• Diligently keeping up to date with and following all applicable company standard operating procedures (SOPs) to meet quality standards
• Performing quality checks and proofreading for accuracy
• Managing multiple concurrent projects across a range of therapeutic areas, ensuring projects are delivered on agreed timelines
• Monitoring assigned tasks and managing own workload, taking ownership, and anticipating capacity issues and potential solutions

Candidate Profile
• A degree in medical sciences or equivalent, e.g., MBBS, Dentistry, PhD in Healthcare, Pharmacology
• Preferably, a relevant certificate in medical writing, regulatory affairs, etc
• 5+ years of full-time work experience in a similar role
• Ability to translate complex scientific or medical information into clear, simple language
• Experience with standard IT applications, Google Suite, MS Office, etc
• The ability to interpret medical and clinical data
• Effective time management and excellent communication skills, both written and verbal
• Ability to work in a fast-paced and changing environment, prioritizing tasks along the way

Additional Information
Experience : 5+ years
Qualification : A degree in medical sciences or equivalent
Location : Hyderabad, Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Business Services & Support
End Date : 30th October 2025