Senior Medical Writer - UK/EU - Remote

Worldwide Clinical Trials; United Kingdom; Remote; GBP 40,000 - 60,000; Full time

Job summary

A global CRO is seeking a Medical Writer to lead the preparation of study documents and collaborate with various departments. The role requires excellent English skills, project management abilities, and a degree in life sciences. Join a diverse team committed to improving lives through innovative approaches.

Qualifications

• Minimum of 4 years of experience as a Medical Writer or similar role.
• Ability to interpret data accurately and communicate findings clearly.

Responsibilities

• Prepare and lead the medical writing team on Phase I-IV study documents.
• Collaborate with other departments to develop Pre-IND documents.

Skills

English

Project Management

Time Management

Education

University/college degree in life sciences

Tools

Microsoft Office

Job description

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, a global team of over 3,500 experts, bright thinkers, dreamers, and doers, changing the way the world experiences CROs for the better.

Our mission is to work with passion and purpose every day to improve lives. We are seeking others who share this pursuit.

Why Worldwide

We believe everyone plays an important role in making a difference for patients and caregivers. From accessible leaders to supportive teams, we are committed to fostering a diverse and inclusive environment that promotes collaboration and creativity. We pride ourselves on being a workplace where people thrive by being themselves and are inspired to excel. 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 for ongoing training and career development opportunities.

What you will do

1. Prepare and lead the medical writing team on Phase I-IV study documents such as protocols, amendments, informed consent documents, clinical trial reports (CTRs), CTR narratives, Investigator Brochures, and other study-related documents in accordance with regulatory requirements (USA, Europe, and ROW) and WCT SOPs.
2. Lead the preparation of applicable study documents outside the USA, including IMPDs, Protocol Lay Summaries, CTR Lay Summaries, and Assents.
3. Collaborate with other departments to develop Pre-IND documents, synopses, briefing books for authorities (FDA, EMA, MHRA, Health Canada, etc.), and update documents based on agency feedback.
4. Manage key document templates in compliance with global regulations.
5. Serve as a publishing point-of-contact with the Publisher for CTRs or other documents as needed.

What you will bring to the role

• Excellent written and spoken English skills.
• Ability to interpret data accurately and communicate findings clearly.
• Strong project and time management skills, with the ability to work independently.
• Flexibility to meet challenging deadlines and manage multiple projects.
• Proficiency in Microsoft Office, especially Word, PowerPoint, Excel, and Outlook.
• Thorough knowledge of applicable regulatory requirements and guidelines (e.g., ICH E3, E6, E9).

Your Experience

• University/college degree in life sciences or related health profession, or equivalent education and experience.
• Minimum of 4 years of experience as a Medical Writer or similar role.
• Availability for domestic and international travel, including overnight stays (valid passport).

We are committed to making a positive impact through our work. To explore other roles, visit our careers page at Discover a world of difference at Worldwide! For more information, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer dedicated to diversity, inclusion, and creating an environment where everyone can succeed. We provide equal employment opportunities regardless of race, ethnicity, religion, gender, sexual orientation, age, disability, or other protected classes.