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Senior Medical Writer

2 weeks ago


Reading, United Kingdom ICON Strategic Solutions Full time

Senior Medical Writer – EMEA or UK ICON 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 Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies. As a Senior Medical Writer you will be supporting a Top-5 pharma company. You have the chance to help our customer to deliver best-in-class regulatory and submission documents. While being stably employed with ICON, you will be fully embedded with our client. What You Will Be Doing Independently produces clinical and regulatory documents in collaboration with the team. These documents may include clinical study level documents such as clinical summary documents, protocols, CSRs, IBs, briefing books and response documents, PIPs .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. Your profile Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Minimum requirement of a bachelor’s degree; Master’s degree preferred. 3-5 years Medical Writing experience & other relevant pharmaceutical experience combined with scientific and regulatory knowledge. Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured messages. Proficient in independently writing several types of clinical/regulatory documents (protocols, CSRs, etc.) including leading creation, coordination of the authoring functions, facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved. 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Equal Opportunity Employer 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. #J-18808-Ljbffr