Stellenbeschreibung
Icon Clinical PLC
Germany, Franckfurt
Principal Medical Writer in Franckfurt, Deutschland is listed on Jobeax. Browse 40,000+ vacancies available.
Principal Medical WriterICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients https://jobeax.com/link/efwgtdJQib1V21VG a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and https://jobeax.com/link/H62qupVMzkVd9GHT 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 https://jobeax.com/link/dQlVR1ZOpxEumoRs role is permanent and is single-client dedicated to a global biotech companyWhat You Will Be Doing:Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives. Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations. Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents. Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate. #LI-NR1#LI-Remote Your Profile:- A Bachelor's degree in a life science discipline, with Master's degree in life science discipline preferred.• At least 6 years of medical writing experience in the biopharmaceutical/CRO industry required.- Regulatory writing experience - Clinical Study Reports, IBs, Protocols - Experienced writer who has ideally led submissions in addition to other document experience- Oncology experience would be a plus• Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.• Proficiency in organizing and communicating clinical information necessary.• Strong communications, organizational, time management, and project management skills are https://jobeax.com/link/sXtfTulmqWsKTUTZ with ICON is contingent upon having the legal right to work in the country where the role is https://jobeax.com/link/97peIn6rwWNrwEK0 & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career https://jobeax.com/link/cISEJDp1mDZ1INPW may include:Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and https://jobeax.com/link/bZYgw6BMnqJfM0kI our careers site to read more about the benefits ICON https://jobeax.com/link/JT9FPQDsHs4PHmvK and AccessibilityICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and https://jobeax.com/link/Grm9O8J29b2dq59c you require reasonable accommodations during the recruitment process, please let us know or submit a request https://jobeax.com/link/RuPwFoz4oC3sb4wk you a current ICON Employee? Please click here to applySummaryLocation: Germany, Frankfurt; Netherlands, Assen; France, Paris; Switzerland, Zurich; Spain, Barcelona; Regional Great Britain (Northern Ireland); UK, Reading; Portugal, Lisbon; Italy, FlorenceType: Full time
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