Principal Medical Writer

Principal Medical WriterICON plc is a world-leading healthcare intelligence and clinical research organization. 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 We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards. This role can be filled at Senior or Principal Medical Writer level 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. What You Will Be Doing: Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity. 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 Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development. Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards. Your Profile: • Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred. - Minimum 5 years of experience as a regulatory medical writer• Significant experience in medical writing, particularly in regulatory submissions and clinical documentation.• Strong understanding of regulatory requirements and industry standards for clinical writing.• Exceptional writing and editing skills, with a keen eye for detail and clarity.• Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.• A commitment to maintaining high standards of quality and compliance in all medical writing activities. #LI-Remote #LI-NR1 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 maximize 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 site to read more about the benefits ICON offers. 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, 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 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. Are you a current ICON Employee? Please click here to apply