Senior Medical Writer

at  Worldwide Clinical Trials

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 3,500+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

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 2 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.

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).