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Associate Director Clinical Regulatory Writing

1 month ago

Boston, United States AstraZeneca Full time
Job Description

Join us at AstraZeneca, where we are using cell therapy to revolutionize the treatment of life-threatening immune-mediated diseases. Our exceptional team is working on the groundbreaking area of cellular therapies, and we are investing in internal capabilities to discover and accelerate the delivery of next-generation cellular therapies for patients. As part of our Clinical Regulatory Writing team, you will play a crucial role in bringing these transformative therapies from the lab to life.

We are now recruiting an Associate Director, Clinical Regulatory Writing (CReW), Immunology Cell Therapy Submission Lead. As part of a clinical delivery or submission team, provides strategic communications leadership to projects, establishes communication standards and best practice, and continuously advocates for quality and efficiency. Authoring strategic clinical-regulatory documents and providing critical review to achieve high-quality standards, utilizing best practices for document and accelerated submission delivery.

This opportunity is available at our Seaport, MA (USA) location.

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 program 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 (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 addresses information requirements.
  • Be a strategic thinker and demonstrate strategic review capabilities.
  • Proactively collaborative 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.

Essential for the Role:

  • Bachelor’s degree in Life Science or appropriate discipline.
  • 5 years of experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organization environment.
  • Experience authoring submission level documents, particularly in Immunology Cell Therapy.
  • Understanding of the drug development process from development, through life-cycle 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 (Ph.D.) with 3 years of experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organization environment.

As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here:

Kendall Square Press Release

Date Posted

23-Jul-2024

Closing Date

04-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.