Medical Writers (Clinical Regulatory) – all levels Job at AstraZeneca

AstraZeneca Gaithersburg, MD 20878

Medical Writers (Clinical Regulatory) – all levels

Location: Gothenburg, SE; Gaithersburg, US; Barcelona, ES or Mississauga, CA.

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. We expect employees to be on-site for a minimum of three days per week and are therefore unable to offer remote based working.

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. It is therefore imperative you have some experience in writing regulatory documents, otherwise we won't be able to consider your application.

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

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 (optional)


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 2023.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en




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