At 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.The Position
Regulatory Medical Writer
Roche India - Roche Services & Solutions
Chennai or Hyderabad
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.Roche is an innovative biotechnological company offering exceptional career paths and great benefits for fresh graduates and outstanding professionals alike. To achieve that, we are continuously expanding and looking for new talent to join our transforming Services & Solutions Center.
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.
The Opportunity
As a
Regulatory Medical Writer,
you must uphold the highest standards of scientific accuracy, quality, and compliance with all applicable industry guidelines, local and international.As a qualified expert, your responsibilities will include, but are not limited to:
- 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
Who You Are
We are looking for upbeat, dynamic individuals who are highly involved and passionate about medical writing. Ideally, you should have:
