Regulatory Content Strategist (Medical Writer)

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

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.

The Pharma Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization.

We make decisions quickly and strategically as the environment & landscape evolves.

We innovate.

Within the PDR Data and Content Chapter, we are responsible for end-to-end data interpretation, generation and execution of content strategy, insight generation to guide submission strategy, and leadership of submission planning and management for clinical projects in the Roche portfolio in order to develop and maintain Roche product permits/licenses to meet the needs of our patients.

We understand how data and information contribute to the strategy and quality of submissions, and thus, deliver high-quality submissions to global Health Authorities for products throughout their development lifecycle to facilitate reviews and approvals.

We ensure audit and inspection readiness and representation.

Additionally as a member of PDR,  individuals understand how data and information contribute to the quality of our submissions

As a member of this Chapter, you will drive and manage data interpretation and content, including medical writing, from initiation to approval, developing data and content standards, driving and articulating key messages, content creation, strategic reuse of content, and implementing automation and next-generation systems and tools.

Additionally, you may participate in industry associations to shape and influence data, content, technology, and submission standards.

The Opportunity:


* Assists with the preparation of regulatory content in accordance with applicable regulatory guidelines/Roche standards/SOPs.

Regulatory content may include the Clinical Dossier and/or Suite of Safety reports for drugs or medical devices


* Plans content and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate


* Reviews documents for organization, clarity, scientific standards, and consistency of content, data, and messaging.

Resolves issues with cross-functional contributors.

Ensures compliance with regulatory requirements


* Manages the review and approval process


* Ensures that documents are published i...