Senior Medical Writer - Early Development Services

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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. Position Overview We are excited to expand our Medical Writing Early Development Services Team in Europe! As a Senior Medical Writer, Early Development Services, you will be a trusted scientific author shaping key clinical and regulatory documents that move early-phase programs forward. You will transform complex clinical data into clear, high-quality deliverables while partnering closely with cross-functional teams to drive strategy, quality, and execution. Key Responsibilities: Serves 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 assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results. May assist in program management activities. Duties could include assisting with developing timelines, budgets, forecasts for assigned deliverables. Represents the department at project launch meetings, review meetings, and project team meetings. Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred. Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 5+ years). Experience working in the pharmaceutical/CRO industry required. Experience in managing and directing complex medical writing projects required. Early phase experience is preferred. Knowledge, Skills, and Abilities: Excellent organizational and program management skills. Proven leadership skills to manage and mentor a team of medical writers. Extensive knowledge of regulatory guidelines and drug development processes. Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders. Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards. Self-motivated and adaptable. Excellent judgment; high degree of independence in decision making and problem solving. 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. 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.