Senior Principal Medical Writer

As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Principal Medical Writer you will be fully dedicated to a Top-5 pharmaceutical company. While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer-term career.

This role is home based in the UK or Europe

What you will be doing:

• Perform medical writing tasks, especially medical writing tasks of high complexity and critical to project(s) and strategic area
• Clinical trial reports (CTRs)
• Lay summaries of clinical trial results
• Investigator brochures (IBs)
• Clinical evaluation plans (CEP) and Clinical evaluation reports (CER)
• Paediatric investigational plans (PIPs)
• Clinical summary and overview documents in CTD/eCTD format for regulatory submissions world-wide (including investigational medicinal product dossiers (IMPDs), investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs) & Replies to questions from authorities
• Protocol, protocol outlines and SI/IC
• Act as expert and advisor in medical writing within therapeutic area, including responsibility for establishing new and improved methods within field of expertise
• Drive discussion, ensure decisions are taken and shape project strategy for implementation into documents
• Drive the sharing of better practices across projects/indications within the therapeutic area
• Guide, coach and set direction for others

#LI-NR1

• 5 years of experience in medical writing
• Medical Writing experience in Protocols and Investigator brochures
• Submission experience (or components of submission)

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.