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.

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.

We are excited to bring a Senior Medical Writer to join our Data and Content Strategy team.

The Opportunity:

Leads a team of Content Strategists and/or cross-functional teams in development and execution of the content strategy for submission to global regulatory authorities 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. Ensures proper planning and resourcing of all documents assigned to the writing team, including work to be outsourced

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 and internal processes

Serves as Roche liaison for project purposes, including outsourced work assignments (planning, writing, review of documents)

Is a key strategic participant in functional and cross functional teams and actively contributes to best practices and continuous improvement initiatives and projects

Partnering with key stakeholders, working on the molecule portfolio, or continuing to key initiatives that shape our technical, business and healthcare environments

Maintains up-to-date knowledge of key regulatory, scientific, and medical topics relevant to drug development and disease/therapeutic areas and acts as a mentor to new or less experienced Content Strategists

Who you are:

Degree in Life Sciences or equivalent with 5-7 years of relevant experience in the pharmaceutical/biotechnology industry, demonstrating independent project delivery and leadership. Experience in leading cross-functional teams.

Familiar with regional/global drug and device development processes, regulations, and guidelines (e.g., GxP, GCP, ICH, ISO, and MDR/IVDR) and an understanding of GVP and GCP principles, including data integrity.

Demonstrated expertise in clinical, safety and/or device regulatory documentation throughout the product lifecycle, from early development through post-marketing activities.

Ability to independently analyze and synthesize data and non-clinical and clinical concepts from a broad range of disciplines.

Proven ability to drive outcomes in global filings (strongly preferred) and other regulatory projects by collaborating across diverse, cross-functional teams, leveraging strong communication and interpersonal skills to build trust, foster collaboration, and resolve conflicts in matrixed environments.

Excellent administrative and project planning skills, with proficiency in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault; detail-oriented, creative thinker with a curiosity to learn and adapt to change, and fluent in English (verbal and written).

Our team follows a hybrid work structure (majority of days on-site is required).

Relocation benefits are not available for this job posting.

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.