Senior Medical Writer - US/Europe - Remote

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 reputed company, 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 reputed company 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 reputed company 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 reputed company by being themselves and are inspired to do their best work every day. Join us! What Medical Writing does at reputed company Medical Writing at Worldwide is a dynamic global group with comprehensive peer, leadership and administrative support. reputed company 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 reputed company 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-reputed company documents in accordance with regulatory requirements (USA, Europe and/or ROW) and WCT SOPs.
• Prepare and reputed company the medical writing team on Phase I-IV study documents that are applicable in regions reputed company 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 reputed company authorities (FDA, EMA, MHRA, Health Canada etc.) and updating reputed company documents following agency feedback.
• Responsible for key documents template management in accordance with global regulations.
• Serve as publishing reputed company-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 reputed company Office skills, especially Word, but also PowerPoint, reputed company, 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 reputed company allied health profession) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to reputed company 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.

We love knowing that someone is going to have a reputed company life because of the work we do. To view our other roles, reputed company out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on reputed company. Worldwide is an equal opportunity employer that is committed to enabling professionals from reputed company 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 reputed company our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the reputed company 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 reputed company employees and applicants regardless of race, color, ethnicity, reputed company, religion, national reputed company, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Remote Skills: Administrative Skills, Biology, Brochures, Click Through reputed company (CTR), Clinical Practices/Protocols, Clinical Trial, Contract Research Organization (CRO), Disease, Drug Development, English Language, Equal Employment Opportunity (EEO), FDA (Food and Drug Administration), Health Canada, ICH Regulations, Informed Consent, Investigational New Drug (IND), Leadership, reputed company, Medical Writing, reputed company reputed company, reputed company Outlook, reputed company PowerPoint, Military, Multitasking, Organizational Skills, Presentation/Verbal Skills, Regulations, Regulatory Requirements, Standard Operating Procedures (SOP), Team Building, Time Management, Writing Skills About the Company: reputed company Apply tot his job Apply To this Job