Regulatory Data & Content Specialist – Content Strategy

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 people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. 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 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 3 years of relevant 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

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche’s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

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