Senior Medical Writer

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

As a Senior 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.

What you will be doing:

Perform medical writing tasks, including but not limited to the development of

• 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 globally (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
• Deliverables (briefing book, slides) for Advisory Committee Meetings
• Publications (abstracts, posters and slide presentations for conferences and other scientific meetings, and manuscripts for scientific journals) - instrumental for marketing activities
• Protocol, protocol outlines and Subject Information/Informed Consent
• Other ad-hoc documents (e.g. meeting packages)

• Drive discussion, ensure decisions are taken and implement project strategies in documents

You are:

Education

PhD degree or Master’s degree with relevant experience

Experience

• ≥3 years’ experience as medical writer or equivalent
• Experience from the pharmaceutical industry or equivalent
• Experience with a broad range of different medical writing tasks

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.