Medical Writing

  • location: Raleigh, NC
  • type: Contract
  • salary: $72.25 - $85 per hour

job description

Medical Writing

Medical Writer - Remote

Job Summary

Serves as a senior medical writer on clinical study or regulatory project teams. Plans and coordinates report-writing activities with dependent staff roles to ensure satisfactory completion of all writing projects, as well as mentors and leads less experienced medical writers on complex projects.

Job Responsibilities

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on inter-department and intra-department project teams with minimal supervision. Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas.
  • Creates writing deliverables that include, but may not be limited to:

    • clinical study protocols and clinical protocol amendments
    • clinical study reports
    • clinical development plans
    • IND submissions and annual reports
    • Integrated summary reports
    • NDA and (e)CTD submissions
    • investigator brochures
    • clinical journal manuscripts, clinical journal abstracts, and client presentations
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Serves as peer reviewer on internal review team.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
  • Performs on-line clinical literature searches, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
  • Performs other work-related duties as assigned.
  • Minimal travel may be required (less than 25%).
Education & Qualifications

  • BA/BS degree in life sciences, clinical sciences, English/journalism, or equivalent related experience.
  • Extensive progressive experience in medical and/or scientific writing or equivalent education and experience.
  • Advanced degree preferred.
  • 5 - 7 years of experience
  • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
  • Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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