Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical delivery or submission team, the Associate Director provides strategic communications leadership to projects, establishes communication standards and best practice, and continuously advocates for quality and efficiency. The Associate Director also authors strategic clinical-regulatory documents and provides critical review to achieve high-quality standards, utilising best practices for document and accelerated submission delivery.

This opportunity is available at our office in Mississauga, Ontario, Canada.

We expect employees to be on-site for a minimum of three days per week, and are therefore unable to offer remote-based working.

What You Will Do

The Associate Director, CReW, is expected to:
• Independently manage clinical regulatory writing activities across a portfolio of work.
• Author clinical-regulatory documents within a programme by ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied.
• Drive the development of the clinical Submission Communication Strategy.
• 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 information requirements.
• Be a strategic thinker and demonstrate strategic review capabilities.
• Proactively collaborate with other functions at the programme level.
• Support the development of others in Clinical Regulatory Writing.
• Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the Clinical Regulatory Writing function on drug and non-drug projects, as required.

Essential for the Role:
• A Life Sciences degree in an appropriate discipline.
• 5-9 years of experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organisation environment.
• Experience leading submission authoring and authoring submission-level documents.
• Understanding of the drug development process from development through lifecycle management.
• Experience in working within, and contributing to, large, diverse, matrix teams.
• Excellent verbal and written communication skills in English.
• In-depth knowledge of the technical and regulatory requirements related to the role.
• Flexibility in adapting to changing circumstances and latest information.

Desirable Qualifications:
• Advanced degree in a scientific discipline, such as a PhD.