Medical Writer II

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!

SUMMARY: 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).

Responsibilities

Tasks may include but are not limited to:

• 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.
• Attend project-related meetings, as needed.
• Review and perform MW QC review of documents, as needed.
• May serve as publishing point-of-contact in conjunction with the Publisher for CTRs or other documents, as needed.
• Identify and appropriately communicate risks associated with document delivery and propose mitigation plans.
• Advise project teams and Sponsors on medical writing-related issues.
• Complete Medical Writing department training.
• Complete project-specific and company training, as assigned.
  
  

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Other Skills And Abilities

• 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.
• Ability to plan own work in advance and ability to multi-task.
• Attention to detail—style, consistency, grammar, syntax, scientific accuracy.
• Knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9).
  
  

Requirements

 

• 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).
  
  

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 respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.