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. Its 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. Thats 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 Roches 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:

• 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

The Benefits

Development opportunities: Roche is rich in learning resources. We provide constant development opportunities free language courses and training the possibility of international assignments internal position changes and the chance to shape your career.

A global and diverse community: At Roche we cooperate debate make decisions celebrate successes and have fun as a team. Our leadership is extremely focused on people creating a strong and inclusive culture so you always have the chance to share your opinion.

Explore What the RSS is About

Discover the Roche Services & Solutions Center and how we work together as a truly global team!

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. Roche fosters diversity equity and inclusion representing the communities we serve. When dealing with healthcare on a global scale diversity is an essential ingredient to success. We believe that inclusion is key to understanding peoples varied healthcare needs. Together we embrace individuality and share a passion for exceptional care. Join Roche where every voice matters.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.