Senior Medical Writer

Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What Medical Writing does at Worldwide Clinical Trials Medical Writing at Worldwide is a dynamic global group with comprehensive peer, leadership and administrative support. Our team liaises with Subject Matter Experts across the company, including regulatory strategists and clinical methodologists in high level protocol and clinical development discussions. We also author a wide range of documents across many therapeutic areas. Join us and discover opportunities for ongoing training and career development. What you will do • Prepare and lead the medical writing team on Phase I-IV study documents such as protocols and protocol amendments, informed consent documents and assents, complete clinical trial reports (CTRs), CTR narratives, Investigator Brochures, and other study-related documents in accordance with regulatory requirements (USA, Europe and/or ROW) and WCT SOPs. • Prepare and lead the medical writing team on Phase I-IV study documents that are applicable in regions outside of the USA, including but not limited to IMPDs, Protocol Lay Summaries, CTR Lay Summaries, Assents etc. • Work with other departments in Worldwide preparing and leading the development of Pre-IND documents, synopsis, briefing books for all authorities (FDA, EMA, MHRA, Health Canada etc.) and updating all documents following agency feedback. • Responsible for key documents template management in accordance with global regulations. • Serve as publishing point-of-contact in conjunction with the Publisher for CTRs or other documents, as needed. What you will bring to the role • Excellent written and spoken English. • Ability to accurately interpret data and express findings in a clear and concise written manner. • Excellent project/time management and organizational skills, and ability to work independently. • Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects. • Comprehensive Microsoft Office skills, especially Word, but also PowerPoint, Excel, and Outlook. • Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9). Your Experience • University/college degree (life science or related allied health profession) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to perform the above responsibilities. • Minimum of 4 years of experience as a Medical Writer or equivalent role as determined by management to have sufficient skills and knowledge. • Minimal travel required, but must be available for domestic and international travel, including overnight stays (valid passport).• Responsible for key documents template management in accordance with global regulations. • Lead the writing of key documents including protocols and CTRs with minimal support. • Act as the key Medical Writing point of contact for their projects with minimal support. • Proactively contribute creative ideas, concepts or suggestions to provide added value to projects. • Ability to work independently. • Ability to lead a Medical Writing team working on a document with minimal support. • Coordinate internal (project team) and Sponsor document review cycles. • Organize and lead document kick-off meetings, as required. • Attend project-related meetings and represent Medical Writing, as needed. • Perform peer review of documents, as needed. • Perform MWQC review of documents, if required. • Serve as publishing point-of-contact in conjunction with the Publisher for CTRs or other documents, as needed. • Create and manage project-specific timelines, adaptation of timing and milestones based on Sponsor needs/feedback. • Identify and appropriately communicate risks associated with document delivery and propose mitigation plans. • Advise project team and Sponsors on medical writing-related issues and offer solutions with minimal support. • Complete Medical Writing department training. • Familiarity with budgeted/scoped work and ability to identify out of scope requests. • Complete project-specific and company training, as assigned. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. OTHER SKILLS AND ABILITIES: • Excellent written and spoken English. • Ability to accurately interpret data and express findings in a clear and concise written manner. • Excellent project/time management and organizational skills, and ability to work independently. • Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects. • Comprehensive Microsoft Office skills, especially Word, but also PowerPoint, Excel, and Outlook. • Ability to communicate with professionals from a variety of backgrounds. • Ability to plan own work in advance and ability to multi-task. • When acting as lead writing on a document, ability to plan and coordinate the workload of supporting team members. • Attention to detail-style, consistency, grammar, syntax, scientific accuracy. • Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9). REQUIREMENTS: • University/college degree (life science or related allied health profession) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to perform the above responsibilities. • Minimum of 4 years of experience as a Medical Writer or equivalent role as determined by management to have sufficient skills and knowledge. • Available for domestic and international travel, including overnight stays (valid passport).We love knowing that someone is going to have a better life because of the work we do.To view our other roles, check out our careers page at ! For more information on Worldwide, visit or connect with us on .Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and