Lead Medical Writer

4 weeks ago

Canada Worldwide Clinical Trials, LLC Full time

About Us

Worldwide Clinical Trials (Worldwide) is a premier global contract research organization (CRO) that collaborates with biotechnology and pharmaceutical firms to deliver tailored solutions that facilitate the development of new therapies – from initial discovery to market introduction. Grounded in our scientific legacy, we focus on therapeutic areas such as cardiovascular, metabolic, neuroscience, oncology, and rare diseases, enabling us to devise adaptable strategies and swiftly address challenges for our clients. Our dedicated team of over 3,500 professionals operates in more than 60 countries, united in our mission to enhance patient outcomes through innovative treatments.

Why Choose Worldwide

We recognize that every individual contributes significantly to making a positive impact on patients and their families. With approachable leadership and cohesive teams, we are dedicated to fostering an environment where professionals from diverse backgrounds can excel. We emphasize the importance of a diverse and inclusive workplace that encourages collaboration and creativity. We take pride in being a company where individuals can thrive by being authentic and are motivated to perform at their best every day.

The Role of Medical Writing at Worldwide

The Medical Writing team at Worldwide is a vibrant global collective that benefits from extensive peer, leadership, and administrative support. Our writers collaborate with Subject Matter Experts throughout the organization, including regulatory strategists and clinical methodologists, to engage in high-level discussions regarding protocols and clinical development. We produce a variety of documents across numerous therapeutic areas. Join us to explore opportunities for continuous training and professional growth.

Key Responsibilities

Responsibilities may include, but are not limited to:

  • Draft study documents such as protocols, informed consent forms, clinical study reports (CSRs), patient narratives, and other materials in compliance with regulatory standards and internal SOPs.
  • Act as the publishing liaison in collaboration with the document coordinator to publish CSRs or other documents as required.
  • Develop and oversee project-specific timelines, adjusting schedules and milestones based on client feedback and requirements.
  • Identify and effectively communicate risks related to document delivery and propose appropriate mitigation strategies.

Qualifications

  • Exceptional written and verbal English skills, with the ability to accurately interpret data and present findings clearly and concisely.
  • Strong project management and organizational abilities, with a capacity to work independently.
  • Adaptability in meeting tight deadlines and evolving requirements while managing multiple projects.
  • Meticulous attention to detail—style, consistency, grammar, syntax, and scientific accuracy.
  • Comprehensive understanding of relevant regulatory requirements and guidelines (particularly ICH E3, E6, and E9).

Experience Required

  • A university/college degree in life sciences or a related field, along with American Medical Writers Association Certification or an equivalent combination of education and experience that equips the individual with the necessary knowledge, skills, and abilities to fulfill the responsibilities outlined above.
  • A graduate degree is preferred.
  • A minimum of 2 years of experience in the clinical pharmaceutical industry, demonstrating proficiency in medical writing.
  • Willingness to travel domestically and internationally, including overnight stays (valid passport required).

We take pride in knowing that our efforts contribute to improving lives through our work.

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