Associate Director, Clinical Regulatory Writing at AstraZeneca

Tjänst Associate Director, Clinical Regulatory Writing
Publicerad 14 Aug 2026
Utgången 13 Sep 2026
Företag AstraZeneca
Plats Västra Götalands län | SE
Anställningsform Full Time

Jobbbeskrivning:

Senaste jobbinformationen från AstraZeneca för tjänsten som Associate Director, Clinical Regulatory Writing. If the Associate Director, Clinical Regulatory Writing lediga tjänsten i Västra Götalands län matchar dina kvalifikationer, vänligen skicka din senaste ansökan eller CV direkt via den uppdaterade Jobkos-portalen.

Observera att det inte alltid är enkelt att söka jobb, eftersom kandidater måste uppfylla vissa krav från företaget. Vi hoppas att karriärmöjligheten hos AstraZeneca för tjänsten som Associate Director, Clinical Regulatory Writing nedan matchar din profil.

Are you passionate about transforming science into clear and compelling regulatory documents that drive successful drug development? We are seeking a talented and experienced Associate Director, Clinical Regulatory Writing to join our CVRM (Cardiovascular, Renal and Metabolism) Clinical Regulatory Writing team in Gothenburg, Sverige. With more than 2,400 employees from over 50 countries, our vibrant Gothenburg site is a truly inspiring place to work - where the history and future of scientific breakthroughs come together. We believe that the diversity of our people is crucial to bringing new discoveries to life.

Accountabilities

The CVRM Clinical Regulatory Writing group provides expert strategic leadership and communications expertise to clinical drug programs, ensuring delivery of high-quality, label-focused documents aligned with project strategy, regulatory requirements, and communications best practices. Role holders not only author critical clinical-regulatory documents but also act as critical reviewers to achieve the highest quality standards. Team members also represent the Clinical Regulatory Writing skill set on both drug and non-drug projects, advocating for best practices and continuous improvement.

Key Responsibilities
  • Provide strategic leadership and communication expertise to clinical drug programs across the CVRM portfolio.
  • Author and critically review clinical-regulatory documents, ensuring the highest regulatory, technical, and quality standards.
  • Represent Clinical Regulatory Writing on project teams, advocating for communication best practices.
  • Provide strategic communications leadership within clinical delivery or submission teams, establishing standards and promoting quality and efficiency.
  • Act as NDA/MAA submission lead, driving the development of the clinical Submission Communication Strategy (cSCS) and successful submission delivery.
  • Lead both internal and external authoring teams and cultivate strong partnerships with vendor medical writers to ensure timely, high-quality document delivery.
  • Translate complex clinical data into clear, concise, and accurate messages tailored to specific audiences.
  • Support the development and upskilling of colleagues within the Clinical Regulatory Writing function.
  • Champion continuous improvement and operational excellence in communications.
Essential Skills/Experience
  • Bachelor's degree in Life Sciences or a related discipline.
  • Significant medical writing experience within the pharmaceutical industry or a Contract Research Organization (CRO).
  • Proven ability to advise and lead communications projects and teams.
  • Strong understanding of drug development and the communications process from early development through to launch and lifecycle management.
  • In-depth knowledge of technical and regulatory requirements relevant to clinical regulatory writing.
Desirable Skills/Experience
  • Advanced degree in scientific discipline (e.g., Ph.D.).
Date Publicerad

10-aug.-2026

Closing Date

30-aug.-2026

Our 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.

#J-18808-Ljbffr

Om tjänsten:

  • Företag: AstraZeneca
  • Tjänst: Associate Director, Clinical Regulatory Writing
  • Arbetsplats: Västra Götalands län
  • Land: SE

Så här skickar du in en ansökan:

Efter att ha läst och förstått kriterierna och minimikraven som förklaras i jobbannonsen Associate Director, Clinical Regulatory Writing at the office Västra Götalands län ovan, vänligen färdigställ dina ansökningshandlingar såsom personligt brev, CV, kopia av examensbevis och andra bilagor. Skicka in via länken 'Nästa sida' nedan.

Nästa sida »

Liknande lediga jobb

Claim 75% Off Hosting