Homeoffice 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.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 DoingPerform 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 AreEducationPhD degree or Master’s degree with relevant experienceExperience

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

What ICON Can Offer YouOur 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/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.https://careers.iconplc.com/reasonable-accommodationsInterested 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.