Medical Writing Manager - U.S. Remote

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 a Medical Writing Manager does at Worldwide 

The Medical Writing Manager is responsible for managing medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget and to written, scientific, and ethical standards in accordance with regulatory requirements and WCT standard operating procedures (SOPs).

What you will do

• Manage the process and delivery of study documents such as protocols, informed consent documents, clinical study reports (CSRs), patient narratives, and other study documents

• Manage the process and delivery of product documents such as investigator drug brochures, summary documents, and other documents

• Manage direct reports (internal employees or vendors), as assigned

• Perform review and QC of documents, as needed

• Advise project team and clients on medical writing-related issues

What you will bring to the role

• Expert knowledge of medical writing principles and application

• Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner

• Superior knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9)

What you will bring to the role

• University/college degree (life science or related allied health profession) and American Medical Writers Association Certification or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities.

• Graduate degree preferred

• Minimum of 8 years of clinical pharmaceutical industry experience including medical writing

• Thorough knowledge of applicable regulatory guidelines related to medical writing

• A demonstrated track record of success in medical writing and managing vendors

• Available for domestic and international travel, including overnight stays (valid passport)

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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is res