Senior Medical Writer - US/Canada - Home-based

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.

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?

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.