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Global drug and device development services

Senior Medical Writer

Technical WritingConfirmed live in the last 24 hours
Full-timeRemote in USANo salary listedRemote

About the Job

Requirements

  • A bachelor's degree in a relevant scientific discipline or healthcare-related field is required.
  • Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses is required, along with writing, editing, and proofreading skills.
  • A strong understanding of regulatory requirements, including ICH-GCP, FDA, and EMA requirements, governing clinical documents and publications is required, as is experience interacting with regulatory agencies during review and approval.
  • The ability to work in a fast-paced, deadline-driven environment, manage multiple projects simultaneously, and prioritize tasks according to timelines and deliverables is required.
  • The ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making is required.

Responsibilities

  • Lead the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports, investigator brochures, and regulatory submissions, ensuring accuracy and clarity.
  • Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs teams to interpret and analyze clinical trial data and summarize scientific findings.
  • Participate in planning and executing clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.
  • Contribute to publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences.
  • Mentor and coach junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering collaboration and continuous learning within the medical writing team.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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