This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Environmental Conditions Office Join us as a Program Manager within our Regulatory Medical Writing team where you will make an Impact at the Forefront of Innovation. As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Regulatory Medical Writing Program Manager, you will lead client programs with high visibility among internal and client teams, often requiring a high degree of client engagement and management; manage client relationships and identify and resolve client management issues; manage and ensure the timely delivery and the quality of multiple program documents; develop, monitor, and adapt project plans, client and program-specific processes, timelines, and budgets/forecasting for programs. Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications. Assist business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.



Ensure compliance with quality processes and requirements for assigned programs both within and between documents within a project. Develops, reviews and manages performance metrics for assigned projects. Provide training for medical writers on processes and technical aspects of program management. Duties could include researching, writing and editing clinical study reports and protocols, summarizing data from clinical studies, writing or providing input on complex clinical and scientific documents such as IBs, INDs, and MAAs, and providing senior review of project materials. Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Experience in managing and directing complex medical writing projects required Additional qualifications in medical writing (AMWA; In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Solid program management skills to include budgeting, forecasting and resource management Extensive knowledge of global, regional, national and other document development guidelines Capable of mentoring and leading junior level staff When you join Thermo Fisher Scientific, you become part of a integral team that values passion, innovation, and a commitment to scientific excellence.

📌 FSP Program Manager Medical Writing EMEA (España)
🏢 Thermo Fisher Scientific
📍 España