Medical Writer II

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Execute medical writing tasks for Phase I-IV studies across the USA, Europe, and the Rest of the World (ROW).

• Lead and manage the medical writing team in the creation of protocols, protocol amendments, informed consent documents and assents, clinical trial reports including efficacy sections, CTR narratives, Investigator Brochures, and other related study documents.

• Oversee the medical writing team in the preparation of documents relevant to regions outside the USA, such as IMPDs, Protocol Lay Summaries, CTR Lay Summaries, and assents.

• Offer innovative ideas, concepts, or suggestions to enhance project value.

• Operate independently with minimal oversight as well as collaboratively within a team.

• Manage internal and Sponsor document review processes.

• Review documents and conduct medical writing quality control checks as necessary.

• Ensure all work adheres to Sponsor specifications, regulatory standards, Worldwide quality management guidelines, timelines, accuracy, efficiency, budgets, and scientific and ethical benchmarks.

⛳️ Requirements

• Exceptional written and verbal English communication skills.

• Proficient in interpreting data and conveying findings clearly and concisely in written format.

• Strong project/time management and organizational abilities.

• Capability to work autonomously and collaboratively as part of a team.

• Adaptability in meeting tight deadlines and shifting requirements while handling multiple projects.

• Comprehensive skills in Microsoft Office, particularly in Word, PowerPoint, Excel, and Outlook.

• Ability to engage with professionals from diverse backgrounds.

• A university or college degree in life sciences or a related allied health field, or an equivalent combination of education and experience.

• At least 3 years of experience in Medical Writing or a comparable role as defined by management.

• Willingness to travel domestically and internationally, including overnight stays, with a valid passport.

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation and pay equity.