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Clinical Regulatory Writers

Location Gothenburg, Västra Götaland County, Sweden Cambridge, England, United Kingdom Job ID R-103611 Date posted 28/09/2021

Are you a passionate Medical Writer with Clinical and Regulatory authoring experience? Can you envision using your expertise to impact patients’ lives? Join our Clinical regulatory Writing department to make a purposeful difference!

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

We have a range of Clinical Regulatory Writing opportunities available across the early and late portfolio - including Director, Associate Director and Manager roles - and we want you to join us!

As a team, we author clinical and regulatory documents that align with project strategies, regulatory requirements and communications best-practices. We support AstraZeneca’s core therapeutic areas in all phases of clinical development, playing a key part in delivering medicines to patients most in need as swiftly as we can.

Whichever role you’re successful in, you’ll be joining an extraordinary team with an outstanding record of achieving successful submissions and approvals.

Essential for the role

We believe that you hold a Bachelor's degree in life sciences at a minimum, and if you have a MSc or PhD, this will be an advantage. Your education is further complemented by regulatory writing experience from the pharmaceutical industry. Collaboration is key and you have a track record of running fruitful and effective partnerships, both internally and externally. We also believe that you share our passion for applying medical writing expertise to reach our goal to change lives.

  • Solid understanding of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical and regulatory documents and submissions

  • Extensive knowledge of current regulatory guidelines relating to regulatory communications

  • Consistent display of ability in project management, thinking (conceptual, analytical and integrative), influencing and team working

  • Flexibility in adapting to changing circumstances or new information

The recruitment process will follow the below steps:

  • Application and CV review 30 minute screening call with a senior member of the team

  • Completion of a medical writing exercise

  • Final interview

Why AstraZeneca?

Work with curious minds in an inclusive culture. Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment.

We strongly believe that everyone contributes with a unique set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximise your skills, abilities and contribution.

You will be offered a competitive salary and excellent benefits, such as extra paid Holiday, Private Medical Benefits, On-site exercise and much, much more.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

This application period is open from August 30 to October 31, 2021 and we will be reviewing and interviewing continuously.

Where can I find out more?

Our Gothenburg site:

Life in Gothenburg:

About BioPharmaceuticals R&D:

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

50056659 F CDMT R&D BioPharmaceuticals

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.