Principal Medical Writer - single sponsor dedicated

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 Denmark or Spain or Poland or Netherlands or Germany or France

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

You are:

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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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 or submit a request here.

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.