Onsite Medical Writer 2

Posted 2 days ago

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About the role

  • Lead Medical Writer handling multiple medical writing projects at IQVIA. Ensuring adherence to standards and timelines in clinical documentation.

Responsibilities

  • Acts as Lead Medical Writer on any type of writing project
  • Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs)
  • Performs senior review of all types of medical writing deliverables
  • Provides feedback and guidance to more junior staff
  • Negotiates timelines and discusses/resolves customer comments
  • Keeps abreast of current medical and/or technical writing/regulatory knowledge
  • Takes a leading role in preparing assigned documents and organizing document reviews
  • Plans and organizes workload for assigned projects and tasks
  • Uses experience and initiative to tackle new/unusual document types

Requirements

  • Bachelor's Degree in life sciences related discipline or related field required
  • Master's Degree in life sciences related discipline or related field preferred
  • Ph.D. in life sciences related discipline or related field preferred
  • At least 3 years of highly relevant experience in regulatory writing
  • In-depth knowledge of clinical study reports (CSR), Common Technical Documents (CTD), protocols, and similar documents
  • Experience in preparing CTDs and/or tackling new/unusual document types/customer requirements
  • Good understanding of common statistical methods used in clinical trials
  • Ability to integrate, interpret, and summarize data from various sources

Benefits

  • Professional development
  • Flexible working hours

Job title

Medical Writer 2

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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