Associate Director, Medical Writing & Regulatory Writing

Hybrid in Boston, MA, US • Posted 12 hours ago • Updated 12 hours ago
Contract W2
2 Months
No Travel Required
Hybrid
$95/hr
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Authorization
  • Communication
  • Conflict Resolution
  • Leadership
  • Management
  • Marketing
  • Medical Writing
  • Problem Solving
  • Process Improvement
  • Project Management
  • Science
  • Supervision
  • Training And Development
  • Writing

Summary

Duration: 2 months, with potential to extend/convert

Schedule: 40 hrs/week Relocation: Full relocation package available

Key Responsibilities:

  • Lead medical writing activities for clinical and regulatory submissions.
  • Independently author complex clinical and regulatory documents.
  • Coordinate clinical sections of complex regulatory filings and MAAs.
  • Provide strategic guidance across clinical programs and cross-functional teams.
  • Lead/manage Medical Writing Science team activities and staff development.
  • Drive process improvements, new technologies, and document development initiatives.
  • Identify risks and develop solutions to complex regulatory writing challenges.

Requirements:

  • Bachelor’s degree in a relevant discipline; PhD or equivalent preferred/required.
  • 8+ years of medical/regulatory writing experience.
  • 2+ years of supervisory or management experience.
  • Strong experience with marketing authorization applications and regulatory submissions.
  • Excellent leadership, communication, problem-solving, and project management skills.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91099677
  • Position Id: 9054559
  • Posted 12 hours ago
Contact the job poster
VC

Vijay Chepyala

Recruiter @ Talent Groups
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