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Associate Director- Clinical Regulatory Writing

2+ years
Not Disclosed
10 Feb. 16, 2025
Job Description
Job Type: Full Time Education: PhD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director – Clinical Regulatory Writing

Job ID: R-215854
Date Posted: 01/13/2025
Career Level: E

Lead the Way in Regulatory Innovation

Champion a strategic approach to regulatory decision-making that supports quick, informed choices and balanced risk-taking. As a solution-oriented regulatory expert, you will play a crucial role in shaping drug development earlier in the product lifecycle.

Be Part of a Team Empowered to Follow the Science

Work at all stages of drug development to turn life-changing science into medicines that make a difference for patients and healthcare professionals worldwide.

About AstraZeneca

At AstraZeneca, we are dedicated to being a Great Place to Work. Our culture champions diversity, collaboration, and lifelong learning, empowering employees to push the boundaries of science.

About the Team

As a diverse and open-minded regulatory team, we accelerate drug discovery and development. By combining knowledge across therapy areas, we drive rapid, global approvals that bring innovative medicines to patients.

About the Role

The Clinical Regulatory Writing Associate Director provides strategic leadership and communication expertise for clinical drug programs. This role involves authoring key clinical-regulatory documents, ensuring high-quality standards, and representing regulatory expertise on various projects.

Responsibilities:

  • Independently manage clinical regulatory writing activities across a complex portfolio.
  • Author complex clinical-regulatory documents, ensuring regulatory, technical, and quality standards.
  • Provide strategic communications leadership and advocate for quality and efficiency.
  • Lead the development of the Clinical Submission Communication Strategy (cSCS) as a submission lead.
  • Manage internal and external authoring teams, partnering with vendor medical writers to ensure timely delivery.
  • Interpret complex clinical data and present it in a clear, concise, and accurate manner.
  • Demonstrate strategic problem-solving and review capabilities.
  • Collaborate proactively with cross-functional teams at the program level.
  • Support the development of Clinical Regulatory Writing Managers.
  • Drive continuous improvement and operational excellence in regulatory communications.

Education, Qualifications, Skills, and Experience

Essential:

  • Life Sciences degree in an appropriate field.
  • Extensive medical writing experience in the pharmaceutical industry or CRO.
  • Strong ability to advise and lead communication projects.
  • In-depth understanding of drug development and regulatory communication processes.
  • Expert knowledge of technical and regulatory requirements related to clinical regulatory writing.

Desirable:

  • Ph.D. in a scientific discipline.

Why Join Us?

We are committed to innovation and continuous improvement to bring life-changing medicines to patients. Our regulatory approach leads the industry, allowing us to work closely with drug development teams to influence early decisions and drive meaningful contributions throughout the lifecycle of our medicines.

What’s Next?

Are you ready to make a difference? Apply now and be part of our mission to push the boundaries of science!

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AstraZeneca is an equal opportunity employer, committed to diversity and inclusion. We comply with all applicable laws and regulations regarding non-discrimination in employment, work authorization, and employment eligibility verification.