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Associate Director, Clinical Regulatory Writing
Company | AstraZeneca |
Address | Mississauga, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-08-06 |
Posted at | 10 months ago |
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.
- Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.
- Author the most sophisticated clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and standard methodology are applied.
- Proactively collaborative with other functions at the program level.
- Independently lead clinical regulatory writing activities across a complex portfolio of work.
- Lead internal/external authoring teams and provide positive relationships with vendor medical writers to ensure delivery to time and quality.
- As part of a clinical delivery or submission team, provide crucial communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
- Support the development of Clinical Regulatory Writing Managers.
- Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements.
- Be a strategic problem solver and demonstrate strategic review capabilities.
- When acting as a submission lead, drive the development of the clinical Submission Communication Strategy.
- We require a minimum of 5 years’ experience
- Life Sciences degree in an appropriate subject area.
- Significant medical writing experience in the pharmaceutical industry or CRO.
- In depth knowledge of the technical and regulatory requirements related to the role.
- Understand drug development and communication process from development, launch through life cycle management.
- Ability to advise and lead communication projects.
- Advanced degree in a scientific field (Ph.D.)
- GTAA Top Employer Award for 9 years
- Learn more about working with us in Canada
- View our YouTube channel
- Learn about our culture
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