Senior Medical Writer - Europe - Remote

Worldwide Clinical Trials; Italia; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization in Italy is seeking a Senior Principal Medical Writer to prepare and lead the development of Phase I-IV study documents. The ideal candidate has a degree in life sciences, at least 4 years of medical writing experience, and excellent English skills. This role involves project management, regulatory compliance, and collaboration across departments. Opportunities for training and career development are provided.

Competenze

• 4+ years of experience as a Medical Writer or equivalent.
• Thorough knowledge of regulatory requirements and guidelines.
• Ability to interpret data clearly.

Mansioni

• Prepare and lead the medical writing team on Phase I-IV study documents.
• Develop Pre-IND documents and briefing books.
• Manage document templates according to global regulations.

Conoscenze

Excellent written and spoken English

Project/time management

Microsoft Office skills

Flexibility with deadlines

Formazione

University/college degree in life sciences or related

Strumenti

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Descrizione del lavoro

Overview

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, a global team of over 3,500+ experts, bright thinkers, dreamers and doers, 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 pursuit.

Why Worldwide: we believe everyone plays an important role in making a world of difference for patients and their caregivers. We are committed to enabling professionals from all backgrounds and experiences to succeed, fostering a diverse and inclusive environment that promotes collaboration and creativity.

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 SOPs.
• Prepare and lead the medical writing team on Phase I-IV study documents 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.
• 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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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 applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

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