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RWD Manager | Regulatory Affairs | Early Access Program

4 months ago

Hitchin, United Kingdom SEC Life Sciences Full time

Join a dynamic Clinical Research Organisation (CRO) that is committed to delivering life-changing medicines to patients across the globe. With a rich blend of expertise in Clinical Development, Clinical Trial Supply, and Early Access Programmes, this organisation offers a unique and seamless service to its pharmaceutical and biotech clients.

Your Role as RWE Manager

In this pivotal role, you will:

  • Lead and manage projects involving Real World Evidence (RWE), integrating these insights with Regulatory Affairs to optimise early access programmes.
  • Design and implement strategies to gather and utilise real-world data, supporting regulatory submissions and enhancing drug development processes.
  • Collaborate with cross-functional teams to ensure seamless integration of RWE in early access and clinical trial phases.
  • Spearhead initiatives to enhance patient access to critical therapies through strategic use of real-world data.

Experience and Qualifications for the RWE Manager Role

The ideal candidate will possess:

  • Proven experience in Real World Evidence application within clinical research or a similar setting.
  • Solid background in managing Early Access Programmes, demonstrating an ability to navigate complex regulatory environments.
  • Expertise in preparing and overseeing regulatory submissions, with a keen understanding of global regulatory requirements.
  • Strong analytical skills with the ability to interpret data and translate it into actionable insights.

Apply Now

This is a 12-month, contract (0.2 FTE) based in the UK. If you're ready to step into a role that offers both challenges and rewarding experiences, we invite you to apply today for immediate consideration. Alternatively, if you're looking for similar opportunities in the sector, please reach out.