Medical Writer II

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

What you will be doing:

• Researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge.
• Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents.
• Exhibits excellent written and oral communication and presentation skills.
• Demonstrates technical expertise and background in the use of medical writing templates and software (eg, Please Review, Documentum-based platforms, etc.).

Ce que vous ferez :

• Effectue des recherches, rédige et corrige des documents cliniques et réglementaires en mettant à profit son expertise fonctionnelle et ses connaissances en développement clinique de médicaments.
• Rédige des documents clairs et concis, notamment des rapports d'étude, des protocoles, des brochures d'investigation, des synthèses et d'autres documents scientifiques.
• Fait preuve d'excellentes compétences en communication écrite et orale et en présentation.
• Démontre une expertise technique et une expérience dans l'utilisation de modèles et de logiciels de rédaction médicale (par exemple, Please Review, les plateformes Documentum, etc.).

You are:

• Bachelor’s degree in science, health profession, or journalism required.
• At least 5 plus years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required
• Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.

Tu es:

• Licence en sciences, profession de la santé ou journalisme requise.
• Au moins 5 ans d'expérience en rédaction pour l'industrie pharmaceutique ou biotechnologique. Au moins 3 ans d'expérience en documentation et soumissions électroniques requises.
• Expérience en tant que rédacteur principal de documents clés inclus dans des soumissions réglementaires majeures aux États-Unis et/ou à l'international requise.
• Expérience en gestion de la rédaction pour une soumission réglementaire majeure aux États-Unis ou à l'international (gestion de projet ou de personnel) souhaitée.

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

At ICON, inclusion & belonging are fundamental to our culture and values. 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, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.