Senior Medical Writer - Europe- Remote

📋 Description

• • Embark on a pivotal role as a Senior Medical Writer at Worldwide Clinical Trials, a globally recognized, mid-size Contract Research Organization (CRO) dedicated to pioneering innovative solutions for the world's most persistent diseases.
• • You will be instrumental in shaping the future of clinical research by authoring and leading the medical writing team on a comprehensive suite of Phase I-IV study documents, ensuring adherence to stringent regulatory requirements across the USA, Europe, and other global regions.
• • Your responsibilities will encompass the meticulous preparation and leadership for critical documents including, but not limited to, study protocols and their amendments, informed consent forms and assents, comprehensive Clinical Trial Reports (CTRs), detailed CTR narratives, and essential Investigator's Brochures.
• • You will also take the lead on documents specifically applicable to regions outside of the USA, such as Investigational Medicinal Product Dossiers (IMPDs), Protocol Lay Summaries, CTR Lay Summaries, and Assents, ensuring global compliance and clarity.
• • Collaborate cross-functionally with other departments within Worldwide, including regulatory strategists and clinical methodologists, to prepare and lead the development of crucial pre-IND documents, synopses, and briefing books for submission to major health authorities like the FDA, EMA, MHRA, and Health Canada.
• • You will be responsible for managing and updating all submitted documents in response to agency feedback, demonstrating a deep understanding of the regulatory review process.
• • Play a key role in the management of global document templates, ensuring they remain compliant with evolving international regulations and guidelines.
• • Act as a primary point-of-contact for publishing activities in conjunction with the Publisher for CTRs and other vital documents, ensuring timely and accurate dissemination of information.
• • Contribute to high-level protocol and clinical development discussions, leveraging your expertise to influence study design and execution.
• • This role offers significant opportunities for professional growth, with access to ongoing training and career development programs within a dynamic and supportive global medical writing team.
• • You will be part of a company culture that values passion, purpose, and innovation, where every team member plays an important role in making a world of difference for patients and their caregivers.
• • Worldwide Clinical Trials fosters a diverse and inclusive environment, prioritizing collaboration, creativity, and the success of professionals from all backgrounds.
• • You will be empowered to be yourself and inspired to do your best work every day, contributing to a workplace where people thrive.
• • The company's mission to improve lives through pioneering, creative approaches is at the heart of everything they do, and as a Senior Medical Writer, you will be a vital contributor to this mission.
• • This position offers the flexibility of remote work across 8 European locations, providing a unique opportunity to contribute to global health initiatives from your home base.
• • You will be expected to maintain a high standard of quality and excellence in all written outputs, reflecting the company's commitment to delivering exceptional results.
• • The role requires a proactive approach to project management, ensuring that all deadlines are met and that changing requirements are handled with agility and professionalism.
• • You will be a key liaison between scientific and regulatory teams, translating complex data into clear, concise, and compliant documentation.
• • Your expertise will be crucial in navigating the complexities of global regulatory submissions and ensuring the successful progression of clinical trials.
• • This is an opportunity to join a growing and respected CRO, contributing to the development of life-changing therapies and making a tangible impact on patient outcomes worldwide.