FSP Senior Medical Writer (EMEA)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Medical Writer - Make an Impact at the Forefront of Innovation The Senior Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients and demonstrates subject matter and therapeutic area expertise. The Senior Medical Writer may assist program manager. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. What You'll Do: • Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. • May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. • Review routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. • Ensure compliance with quality processes and requirements for assigned documents. Provide input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes. • May assist in program management activities. Identify and resolve out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. • Represent the department at project launch meetings, review meetings, and project team meetings. Education & Experience Requirements: • Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). • Experience working in the pharmaceutical/CRO industry preferred • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills, Abilities: • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills • Strong project management skills • Excellent interpersonal skills including problem solving • Strong negotiation skills • Excellent oral and written communication skills with strong presentation skills • Significant knowledge of global, regional, national and other document development guidelines • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. • Great judgment and decision-making skills • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Working Conditions and Environment: • Work is performed in an office environment. • Exposure to electrical office equipment. • Occasional drives to site locations with occasional travel both domestic and international. • Long, varied hours required occasionally. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.