Senior Medical Writer

Job description

Senior Medical Writer At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. As a Senior Medical Writer at ICON, you will lead the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies. What You Will Do: You will take ownership of medical writing deliverables, applying your expertise to complex challenges. Key responsibilities include: Independently produces clinical and regulatory documents in collaboration with Principal/Senior Principal MW assigned to the program. These documents may include clinical study level documents such as Clinical Study Protocols or Clinical Study Reports . This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas. Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies. Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents. Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents you will be directly in contact with QC personnel and publishing specialists who support you in document preparation. Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team. Your Profile: You will have a strong foundation in medical writing, with the experience to work independently and guide others. Required qualifications and experience: 3-5 years of experience as regulatory writer Regulatory experience: Mandatory protocol writing experience in phase II or III, also CSR experience is good to have Bachelor's degree in a relevant scientific discipline or healthcare-related field Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process. Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes. #LI- remote #LI-NR1 Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here . Are you a current ICON Employee? Please click here to apply