Sobi - Swedish Orphan Biovitrum AB (publ)

Principal Medical Writer

Sobi - Swedish Orphan Biovitrum AB (publ)

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $192,000 - $280,000 per year

Job Level

Lead

About the role

  • 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

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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory medical writingclinical writingdocument developmentstoryboardingtechnical writingcomplianceanalytical skillsstrategic thinkingproject coordinationleadership
Soft Skills
communication expertisecoachingteam leadershipcross-functional collaborationmentoringplanningproblem-solvingattention to detailadaptabilityinterpersonal skills
Certifications
Life Science Master's degreePhD