Medical Writer II (US)

Worldwide Clinical Trials; Durham (NC); On-site; USD 67,000 - 132,000; Full time

Job summary

Worldwide Clinical Trials seeks a Late Phase Medical Writer II to perform medical writing for Phase I–IV studies across USA, Europe and ROW. You will prepare protocols, ICFs, CTRs and related documents in alignment with Sponsor specifications and regulatory requirements.

The role requires strong English, excellent writing and project management skills, and willingness to travel domestically and internationally to support global studies with our team of 3,500+ experts.

Qualifications

• University/college degree in life science or related field or equivalent experience.
• Minimum of 3 years of medical writing experience.
• Willingness to travel domestically and internationally (passport required).

Responsibilities

• Lead medical writing on Phase I–IV studies in USA, Europe and ROW.
• Prepare and lead documents such as protocols, ICFs, CTRs and NDA/CTD components.
• Coordinate internal and Sponsor reviews and ensure regulatory compliance.
• Review and QC documents as needed.

Skills

Excellent written English

Project/time management

Microsoft Office

Clear written communication

Independent work

Deadline-driven

Education

Life science degree

Tools

Word

PowerPoint

Excel

Outlook

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, and we are a global team of over 3,500+ 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. 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 The Medical Writer II Does At Worldwide

The Late Phase Medical Writer II is responsible for carrying out medical writing activities on Phase I-IV studies, including USA, Europe and Rest of World (ROW), in accordance with Sponsor specifications in a timely, accurate, and efficient manner, within budget and to the written, scientific, and ethical standards in accordance with regulatory requirements and Worldwide quality management documents (QMDs).

What You Will Do

• Prepare and lead the medical writing team on Phase I-IV study documents such as protocols and protocol amendments, informed consent documents and assents, clinical trial reports (CTRs) including efficacy sections, CTR narratives, Investigator Brochures, and other study documents in accordance with regulatory requirements (USA, Europe and/or ROW) and QMDs.
• Prepare and lead the medical writing team on Phase I-IV study documents that are applicable in regions outside of the USA, including but not limited to IMPDs, Protocol Lay Summaries, CTR Lay Summaries, Assents etc.
• Proactively contribute creative ideas, concepts or suggestions to provide added value to projects.
• Work both independently with minimal supervision and as part of a team.
• Coordinate internal and Sponsor document review cycles.
• Review and perform MW QC review of documents, as needed.

What You Will Bring To The Role

• Excellent written and spoken English.
• Ability to accurately interpret data and express findings in a clear and concise written manner.
• Excellent project/time management and organizational skills, as well as the ability to work independently.
• Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
• Comprehensive Microsoft Office skills, especially Word, but also PowerPoint, Excel, and Outlook.
• Ability to communicate with professionals from a variety of backgrounds.

Your Experience

• University/college degree (life science or related allied health profession) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities to perform the above responsibilities.
• Minimum of 3 years of Medical Writing experience or equivalent role as determined by management to have sufficient skills and knowledge.
• Available for domestic and international travel, including overnight stays (valid passport).

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):

United States of America - $66,500.00 - $131,500.00

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

We love knowing that someone is going to have a better life because of the work we do.