Senior Medical Writer - UK/EU - Remote

worldwide.com; Nottingham, Greater London; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Senior Medical Writer to join their dynamic team. This role involves leading the medical writing team in preparing essential study documents for clinical trials, ensuring compliance with regulatory requirements across various regions. The ideal candidate will possess excellent written communication skills, a strong understanding of life sciences, and the ability to manage multiple projects effectively. Join a forward-thinking company dedicated to improving lives through innovative clinical research and enjoy a collaborative work environment that values diversity and creativity.

Qualifications

• 4+ years of experience as a Medical Writer or equivalent role.
• Strong understanding of regulatory requirements (ICH E3, E6, E9).

Responsibilities

• Lead the medical writing team on Phase I-IV study documents.
• Prepare key documents for regulatory authorities like FDA and EMA.

Skills

Excellent written and spoken English

Project/time management skills

Organizational skills

Ability to interpret data

Flexibility in meeting deadlines

Education

University/college degree in life science or related field

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Microsoft Outlook

Job description

Senior Medical Writer - UK/EU - Remote

Senior Medical Writer - UK/EU - Remote

Apply remote type Remote locations Nottingham, United Kingdom Belgrade, Serbia England, United Kingdom time type Full time posted on Posted Yesterday job requisition id JR100843

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

1. 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.
2. 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.
3. 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.
4. Responsible for key documents template management in accordance with global regulations.
5. 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

1. Excellent written and spoken English.
2. Ability to accurately interpret data and express findings in a clear and concise written manner.
3. Excellent project/time management and organizational skills, and ability to work independently.
4. Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
5. Comprehensive Microsoft Office skills, especially Word, but also PowerPoint, Excel, and Outlook.
6. Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9).

Your Experience

1. 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.
2. Minimum of 4 years of experience as a Medical Writer or equivalent role as determined by management to have sufficient skills and knowledge.
3. 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.

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.