Manager, Clinical Regulatory Writing

at  AstraZeneca

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Role holders provide communications expertise by leading teams in the delivery of high-quality clinical regulatory documents. They work primarily at the document development level with occasional contributions to communication strategy development at a program level. They contribute to improvement projects.

REQUIREMENTS:

• Life Sciences degree in an appropriate discipline.
• Experience in medical communications.
• Strong communication and leadership skills.
• Knowledge of the technical and regulatory requirements related to the role.

DESIRABLE SKILLS & EXPERIENCE:

• Advanced degree in a scientific discipline (Ph.D).
• Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.

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• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
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Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com

ABOUT THE ROLE:

The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company’s core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.

ROLE & RESPONSIBILITIES:

• With limited guidance, lead author and ensure the timely delivery of high-quality clinical-regulatory documents.
• Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied.
• Have the ability to balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.
• Drive the clinical interpretation of data and information and condense it into clear, concise and accurate messages that address customer information requirements.
• Provide critical review of documents for correctness, clarity, completeness and compliance.
• Proactively collaborative with other functions during document development, including, as needed, with external service providers/contractors.
• As part of a clinical delivery team, provide communications support to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
• Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Clinical Regulatory Writing on drug and non-drug projects, as required.
• Work independently but with the guidance and support of more senior members of the group