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Medical Writers (Clinical Regulatory) – all levels

Location Cambridge, England, United Kingdom Gaithersburg, Maryland, United States Gothenburg, Västra Götaland County, Sweden Job ID R-103529 Date posted 16/02/2022

Medical Writers (Clinical Regulatory) – all levels

Location: Cambridge, UK

Competitive salary and benefits

Diverse Minds. Bold Disruptors. Meaningful Impact.

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term meaningful career.

We have a range of medical writing opportunities available across the early and late portfolio including Director, Associate Director and Manager regulatory writing roles.

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

Whichever role you’re successful in, you’ll be joining an extraordinary team who has an outstanding record of achieving successful submissions and approvals. Each role will afford you flexibility in ways of working.

Essential Requirements:

  • Validated regulatory writing experience from within the pharmaceutical industry and a real passion for helping us to achieve our goal of changing lives

  • Bachelor's degree in life sciences; MSc or PhD preferred           

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

  • Ability to drive collaboration with vendors

  • 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:

1.           Application (CV and motivational letter) review

2.           30 minute screening call with a senior member of the team

3.           Completion of a medical writing exercise

4.           Final interview

5.  Informal meeting of various team members

Please include both CV and motivation letter in your application.

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.

This role is open until the 31st December 2022.

Where can I find out more?

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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.