Associate Director Clinical Regulatory Writing

Job Description

Associate Director, Clinical Regulatory Writing

Hybrid Work- on average 3 days/week from office

Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office

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.

This role provides strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high quality standards. They represent the skill on drug and non-drug projects.

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 critical communication excellence to achieve successful submissions and approvals.

Responsibilities:

• Independently manage clinical regulatory writing activities across a portfolio of work.
• Develop clinical-regulatory documents within a program by ensuring that relevant regulatory, technical, and quality standards are met, and that appropriate processes and standard methodologies are applied.
• Lead critical communications for clinical projects, establish standards, and advocate for quality and efficiency.
• When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS).
• Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality.
• Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements.
• Showcase your problem-solving skills and ability to conduct strategic reviews.
• Proactively collaborative with other functions at the program level.
• Support the development of others in Clinical Regulatory Writing.
• Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.

Essential Experience:

• Life Sciences degree in an appropriate subject area.
• Significant medical writing experience in the pharmaceutical industry or CRO.
• Ability to advise and lead communication projects.
• Understand drug development and communication process from development, launch through life cycle management.
• In depth knowledge of the technical and regulatory requirements related to the role.

Desirable Experience:

• Advanced degree in a scientific discipline (Ph.D).

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

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 [email protected]

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.