Worldwide Clinical Trials - Senior Medical Writer – EUROPE – Homebased
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 (WCT), and we are a global team of over 3,000 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.
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 will you do?
- Write study documents such as protocols, informed consent documents (ICFs), investigator brochures (IB), clinical trial reports (CTRs), and other documents in accordance with regulatory requirements and WCT standard operating procedures (SOPs).
- Conduct 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 SOPs.
- Coordinate internal and client document review cycles. Attend project-related meetings, as needed. Advise WCT project team and clients on medical writing-related issues.
- Create and manage project-specific timelines, adapt milestones based on client needs/feedback.
What will you bring to the role?
- Proven experience in writing regulatory documents, including but not limited to, CTRs, protocols, IBs and ICFs.
- 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, including ICH E3, E6, E9, and Regulation (EU) No. 536/2014.
- Ability to communicate with professionals from a variety of backgrounds.
- Diligence – style, consistency, grammar, syntax, scientific accuracy.
- Excellent written and spoken English and competency in Microsoft Office.
- 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.
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
How to Apply
You can apply directly via our website:
Or email your CV to firstname.lastname@example.org