Principal Medical Writer

Posted 3 days 15 hours ago by Jobtailor

Permanent
Full Time
Other
Cambridgeshire, Cambridge, United Kingdom, CB1 0
Job Description
Responsibilities
  • Lead the development of high-quality clinical and regulatory documents (e.g., Investigator's Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submissions) in compliance with global regulatory guidelines (ICH, FDA, EMA) and internal standards.
  • Serve as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs.
  • Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning to ensure alignment with program goals.
  • Manage medical writing projects, including planning, timelines, resource coordination, and delivery to ensure milestones and submission deadlines are met.
  • Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety, etc.) to gather, interpret, and accurately present clinical data.
  • Mentor and support other medical writers, ensuring high-quality, scientifically sound, and consistent deliverables across projects.
  • Review and edit project-related documents to ensure accuracy, clarity, consistency, and compliance with templates and style guides.
  • Attend project and team meetings to provide expert input on document development, study data interpretation, and process improvements.
  • Contribute to and lead process improvement initiatives to enhance efficiency, quality, and consistency in document preparation.
  • Develop, maintain, and refine standard operating procedures (SOPs), templates, and best practices for medical writing.
  • Stay current with evolving global regulatory requirements, industry trends, and therapeutic area knowledge to ensure compliance and innovation.
Requirements
  • Bachelor's degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
  • Minimum of 5+ years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
  • Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
  • Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
  • Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
  • Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
  • Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
  • Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
  • High attention to detail with a commitment to quality, consistency, and scientific accuracy
  • Proficiency in Microsoft Word and document formatting best practices
  • Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools.