Principal Medical Writer

Medical writerMedical writerFull TimeRemoteTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

9 days ago

Salary

$192K - $280K / year

Postgraduate Degree10 yrs expEnglish

Job Description

• Provide communication expertise and lead a strategy-driven approach to authoring key clinical and regulatory documents • Assume primary responsibility for preparation of key clinical and regulatory documents • Provide leadership and project coordination to cross-functional authoring teams • Liaise with senior project staff, develop a storyboard for the submission, and plan document development • Ensure high technical quality of documents in compliance with in-house technical requirements • Coach and develop less experienced Medical Writers

Job Requirements

  • Life Science Master´s degree or PhD
  • A minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge
  • Experience in leading complex global regulatory and clinical writing projects
  • Experience in leading writing activities for major US and/or EMA regulatory submissions
  • Clear understanding of clinical development
  • Advanced knowledge of global regulatory environment and processes
  • Excellent written and spoken English skills
  • Highly developed analytical and strategic thinking

Benefits

  • Competitive compensation for your work
  • Generous time off policy
  • Opportunity to broaden your horizons by attending popular conferences
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment

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