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Principal Medical Writer

Company: Labcorp
Location: Raleigh
Posted on: October 12, 2021

Job Description:

Job Overview:

The Principal Medical Writer is responsible for preparation and coordination of complex clinical study protocols and clinical study reports (CSRs), and other documents as needed.

 

  • Writes and coordinate the development of protocols, CSRs or other clinical documents of any complexity
  • Takes the lead in preparing submission level documents
  • Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate, with support from management. Influence teams to adhere to the relevant medical writing requirements for projects
  • Produces scientific papers, abstracts and/or posters, and presentations.
  • Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines and budget requirements
  • Prepare documents in accordance with Labcorp Drug Development/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
  • Act as medical writing lead and liaison for major clients and partners
  • Represent company at scientific and medical writing forums
  • Keep up to date with developments in Medical Writing
  • Demonstrate detailed knowledge of Medical Writing industry requirements such as ICH and regulatory agency guidelines
  • To regularly demonstrate initiative and ability to deal with medical writing situations independently. Present solutions and convince management and teams to adopt recommended strategies
  • Lead Medical Writing initiatives to develop and improve processes, including new technologies. Persuade other department staff to accept and embrace new working practices
  • Mentor staff and provide guidance and training to department
  • Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences
  • Write and review Labcorp Drug Development SOPs and associated documents
  • Represent department in audits and inter-department working groups
  • Comply with Labcorp Drug Development internal processes and procedures

Education/Qualifications:

Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred

Experience:

  • Typically minimum 6 years medical writing experience, including 3 years as medical writing project lead
  • Experience with Clinical Study Reports (CSR's)
  • Excellent command of written and spoken English
  • Excellent written and verbal communication skills
  • In-depth knowledge of MS Word
  • Excellent organizational and time management ability
  • Excellent knowledge of ICH guidelines applicable to medical writing and other regulatory guidances
  • Excellent understanding of medical/scientific terminology, data analysis and interpretation
  • Appreciation of the business requirements of a contract research organization

Keywords: Labcorp, Raleigh , Principal Medical Writer, Other , Raleigh, North Carolina

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