Senior Medical Writer

1 month ago


Boston, United States Leaman Life Sciences Full time

My client is looking for a Senior Medical Writer acting on most types of regulatory writing projects, keeping abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in clinical drug development.


Key Responsibilities:

  • Preparing all assigned documents; confirming the requirements and full scope, templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
  • Organise assigned projects and other tasks, identifying all project needs, track timelines and ensure timely attention customer requests.
  • Present on Medical Writing processes at bid defense meetings..
  • Complete project finance activities, including monitoring and forecasting budgeted hours.
  • Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.


Key Skills:

  • Bachelor's Degree in life sciences
  • 5 years of highly relevant experience including acting as lead writer for CSRs & CSP
  • A good working knowledge of structure and content requirements of CSRs, protocols, and similar documents with a keen eye to to identify any errors and inconsistencies
  • A good understanding of common statistical methods used in clinical trials and interpretation of their results


100% remote based, anywhere in USA.


For more information contact nicki@leamanlifesciences.com or fatlum@leamanlifesciences.com or click "Easy Apply"


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