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Director, Medical Writing

Date Posted: May 28, 2026
Yearly: USD - USD
Job is expired

Job Detail

  • location_on
    Location Princeton, New Jersey, United States of America
  • desktop_windows
    Job Type: Permanent
  • schedule
    Shift:
  • analytics
    Career Level:
  • group
    Positions:
  • calendar_view_day
    Experience:
  • male
    Gender: No Preference
  • school
    Degree:
  • calendar_month
    Apply Before: Jun 29, 2026
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Job Description

Overview

Genmab is seeking a Director of Medical Writing to advance their medical writing portfolio in clinical and regulatory areas. The role focuses on authoring key clinical documentation and overseeing regulatory submissions, while ensuring quality and compliance with regulatory guidelines.

Key responsibilities

  • Lead planning and authoring of clinical trial protocols, amendments, and reports.
  • Oversee preparation of regulatory submissions and related documents.
  • Represent medical writing on internal teams and collaboration with cross-departmental submission teams.
  • Mentor and guide medical writing staff and new employees.
  • Develop and improve departmental processes and standard operating procedures.
  • Ensure adherence to relevant regulatory guidelines and quality standards.
  • Manage oversight of Medical Writing vendors and CROs.

Required skills

  • Bachelor's degree in science or related area; Master's or advanced degree preferred.
  • 12+ years in clinical or regulatory medical writing in biotech/pharma industry.
  • 10+ years of regulatory Medical Writing experience.
  • Significant experience writing critical clinical documents for major regulatory filings.
  • Advanced familiarity with drug development phases and clinical operations.
  • Experience with Good Clinical Practice (GCP) and regulatory requirements.
  • Experience managing internal cross-functional teams.
  • Proven performance in a leadership role within a similar context.

What the company offers

  • 401(k) Plan with 100% match on the first 6% of contributions.
  • Two medical plan options including HDHP with HSA, dental, and vision insurance.
  • Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave.
  • Access to child and adult backup care and emotional well-being support.
  • Commuter benefits and tuition reimbursement.

Skills Required

Company Overview

Genmab
Los Angeles, Baja California, United States of America
8 Current Jobs Openings

Genmab is dedicated to building extraordinary futures through innovative antibody products and groundbreaking medicines aimed at changing lives and the future of cancer treatment. The company values unique contributions and strives to maintain a glob... Read More

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