Regulatory Content Strategist (Medical Writer)

Overview

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.

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 in collaboration with Regulatory Operations
• Is a key strategic participant in functional and cross functional teams and actively contributes to best practices and continuous improvement initiatives and projects
• Maintains up-to-date knowledge of key regulatory, scientific, and medical topics relevant to drug development, assigned products, and disease/therapeutic areas

Who you are

• Degree in Life Sciences or equivalent with proven experience in the pharmaceutical/biotechnology industry, demonstrating independent project delivery and leadership.
• Proficient in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.
• Familiarity with regional/global drug development processes, regulations, and guidelines (e.g., GxP, GCP, ICH) and an understanding of GVP and GCP principles, including data integrity.
• Strong communication and interpersonal skills, effective collaboration within scientific cross-functional and matrix-based environments, with a strong sense of urgency.
• Ability to work with minimal supervision, excellent administrative and project planning skills, 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.

Who we are

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.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.