Medical Writing Manager (FSP)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Medical Writing Manager (FSP) At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: We are excited to announce that we are looking for an FSP Medical Writing Manager in the United States! Are you an experienced Medical Writer ready to take the next step in your career? Do you thrive leading teams and driving excellence in clinical documentation? If so, we want to hear from you. As a Medical Writing Manager, you will lead a team of talented Medical Writers, and blend scientific expertise, operational leadership, and strategic insight to guide high-visibility projects and shape best-in-class medical writing practices. This role is perfect for a seasoned writer with leadership experience who’s ready to elevate both people and process. What You’ll Do Lead & Develop a High-Performing Team · Manage, mentor, and develop Medical Writers to ensure exceptional performance and continuous growth. · Oversee workload distribution, resource planning, and project assignments. · Conduct regular 1:1s, performance reviews, and coaching conversations. Drive Quality & Delivery Excellence · Supervise and review the preparation of a wide range of medical writing deliverables. · Ensure projects are completed on time and to the highest scientific and regulatory standards. · Serve as a senior reviewer and departmental expert for study design, adverse event reporting, and interpretation of statistical data. · Stay current with ICH, FDA, and global regulatory guidance. Represent the Department Externally · Deliver compelling capabilities presentations to prospective clients. · Collaborate with Business Development and Contracts teams to support bids, budgets, and proposals. Shape Medical Writing Strategy & Processes · Contribute to the development, evaluation, and improvement of SOPs and work practices. · Lead or support internal training programs to ensure new and existing staff are well-equipped for success. What You Bring · Bachelor’s degree in a life science field (advanced degree—PharmD, PhD, MSc—preferred). · 5+ years of relevant regulatory writing experience, including at least 2 years in medical writing within pharma/CRO and 1+ year of leadership responsibility. · Exceptional writing, editorial, and data interpretation skills. · Strong project management ability—forecasting, timelines, resource allocation. · Excellent communication and presentation skills, especially in client-facing settings. · Ability to manage complexity, multitask, and work in a fast-paced environment. What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain five reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.