Regulatory Data & Content Specialist - Content Strategy (Medical Writer)

F. Hoffmann-La Roche Gruppe; Mississauga; Hybrid; CAD 60,000 - 80,000; Full time

Job summary

A leading global healthcare company in Mississauga is seeking a Regulatory Affairs Associate to assist with the preparation of regulatory content. Candidates should have a Degree in Life Sciences and 1-3 years in the biotechnology sector. Responsibilities include managing document reviews, ensuring compliance, and participating in cross-functional teams, with a focus on communication and collaboration. The role follows a hybrid work structure and relocation benefits are not provided.

Qualifications

• 1-3 years of relevant experience in the pharmaceutical/biotechnology industry.
• Familiarity with drug development processes and regulations.
• Fluent in English (verbal and written).

Responsibilities

• Prepare regulatory content in accordance with guidelines.
• Create timelines for review of documents.
• Review documents for consistency and compliance.
• Manage the approval process for documents.
• Maintain knowledge of regulatory and scientific topics.

Skills

Project delivery

Life Sciences knowledge

Communication skills

Collaboration

Attention to detail

Education

Degree in Life Sciences

Tools

G Suite

Microsoft Office Suite

Adobe Acrobat

Veeva Vault

Job description

La 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 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 1-3 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.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.