Senior Medical Writer- Europe - Home-based

Who We Are

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

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 is Medical Writing at Worldwide?

• Dynamic global team with comprehensive peer, leadership and administrative support
• Multi-levelled team, with ongoing training and opportunities for career development
• Writing a wide range of documents across many therapeutic areas
• Liaising with Subject Matter Experts across Worldwide including regulatory strategists and clinical methodologists in high level protocol and clinical development discussions
  
  

What you will do?

• Write study documents such as protocols, informed consent documents (ICF, investigator brochures (IB), clinical study reports (CSRs), and other documents in accordance with regulatory requirements and WCT SOPs.
• Carry out medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, and to the written, scientific, and ethical standards in accordance with regulatory requirements and WCT standard operating procedures (SOPs).
• Coordinate internal and client document review cycles. Attend project-related meetings, as needed. Advise project team and clients on medical writing-related issues.
• Create and manage project-specific timelines, adaptation of timing and milestones based on client needs/feedback.
  
  

What you will bring to the role?

• Proven experience in writing regulatory documents incl. but not limited to CSRs, protocols, IB, ICF
• Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
• Project/time management and organizational skills, and ability to work independently and as part of a team
• Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9)
• Ability to communicate with professionals from a variety of backgrounds. Attention to detail—style, consistency, grammar, syntax, scientific accuracy
• Excellent written and spoken English and competency in Microsoft Office
  
  

Your background

• Minimum of 2 years’ experience of medical writing in the clinical pharmaceutical industry, preferably in a clinical research organization
• Degree in life science or other applicable area, or equivalent combination of education and experience
  
  

Why Worldwide?

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 www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.