Senior Medical Writer

Requisition Number: 7263

Position Title: Senior Medical Writer

External Description:

Who we are

 

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers. Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

 

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 Medical Writing does 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

 

Tasks may include but are not limited to:  

 

• Prepare study documents such as protocols, informed consent documents, clinical study reports (CSRs), patient narratives, and other documents in accordance with regulatory requirements and WCT SOPs. 
• Serve as publishing point-of-contact in conjunction with the document coordinator to publish CSRs or other documents, as needed. 
• Create and manage project-specific timelines, adaptation of timing and milestones based on client needs/feedback. 
• Identify and appropriately communicate risks associated with document delivery and propose mitigation plans. 
  

 

What you will bring to the role

 

• Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner. 
• Excellent project/time management and organizational skills, and ability to work independently. 
• Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects. 
• Attention to detail—style, consistency, grammar, syntax, scientific accuracy. 
• Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9). 

 

 

Your experience

 

• 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 to perform the above responsibilities. 
• Graduate degree preferred. 
• Minimum of 3 years of clinical pharmaceutical industry experience including skills and competency in medical writing. 
• 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 www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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Employment Type: Regular

Community / Marketing Title: Senior Medical Writer

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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CountryEEOText_Description: 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 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. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.