Associate Director, Clinical Regulatory Writing (CReW)

About the role

The Clinical Regulatory Writing Associate Director at AstraZeneca is responsible for independently managing clinical regulatory writing activities, authoring clinical-regulatory documents, providing strategic communications leadership, and driving continuous improvement and operational excellence.

Responsibilities

• Independently manage clinical regulatory writing activities across a portfolio of work.
• Author clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied.
• As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously 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.
• Be a strategic thinker and demonstrate strategic review capabilities.
• Proactively collaborate 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.

Requirements

• Bachelor's degree in Life Sciences in an appropriate subject area
• Minimum of 5 years’ experience
• 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

Qualifications

• Advanced degree in a scientific field (Ph.D.) is desired

Benefits

Annual base pay (or hourly rate of compensation) for this position ranges from $136,784.80 - $205,177.20 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.