Associate Director, Medical Communications

1 month ago

Old Toronto, Canada AstraZeneca GmbH Full time
p>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.

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. b>

  • 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.
  • 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.
  • 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.b>

    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.

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