Associate Director Clinical Regulatory Writing

AstraZeneca • Gaithersburg, MD

243d • $133,042 - $199,563

About The Position

Are you ready to lead the charge in strategic communication excellence? As part of the Clinical Regulatory Writing team, you'll be at the forefront of crafting pivotal clinical-regulatory documents that align with project strategies and regulatory requirements. Our mission is to support core therapeutic areas throughout all phases of clinical development, ensuring successful submissions and approvals. Join us in driving communication leadership and making a tangible impact on drug projects!

Requirements

• Masters degree in Science.
• 2-4 years of active experience medical writing experience in the pharmaceutical industry or CRO.
• Medical writing experience to include: IND (Briefing documents, Clinical study protocols, Paediatric investigational plans, Phase 1 and 2/3 CSR) NDA (Phase 3 CSR, Module 2 Summaries).
• 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.

Nice To Haves

• Advanced degree in a scientific discipline (Ph.D).
• NDA (Phase 3 CSR, Module 2 Summaries).
• Health authority response (HAQ).

Responsibilities

• Independently manage clinical regulatory writing activities across a portfolio of work.
• Author clinical-regulatory documents within a program, ensuring adherence to regulatory, technical, and quality standards.
• Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency.
• Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.
• Lead internal/external authoring teams and collaborate with vendor medical writers to ensure timely and quality delivery.
• Interpret complex data and information, condensing it into clear, concise, and accurate messages that meet customer information requirements.
• Demonstrate strategic thinking and review capabilities.
• Collaborate proactively 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.

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Master's degree