Johnson & Johnson

Director, Regulatory Medical Writing, Oncology

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Titusville • New Jersey • United States

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Salary

💰 $164,000 - $282,900 per year

Job Level

Lead

About the role

  • Assume overall accountability for decision-making within the organization or TA.
  • Proactively identify potential risks and develop strategies to mitigate them.
  • Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents.
  • Represent the MW department with decision-making authority in the R&D organization.
  • Directly lead or set objectives for team projects and tasks.
  • Serve as a liaison between team members and senior leadership within a TA or sub-function.
  • Develop, implement, and drive the institutionalization of departmental process improvements and best practices.
  • Mentor, support, and coach staff at all levels on document planning, processes, and content.

Requirements

  • A university/college degree in a scientific discipline is required.
  • An advanced degree (eg, Masters, PhD, MD) is preferred.
  • Minimum of 14 years of relevant pharmaceutical/scientific experience is required.
  • Minimum of 12 years of relevant clinical/medical writing experience is required.
  • Minimum of 5 years of people management experience is required.
  • Experience providing strategic and operational leadership to medical writing teams across all levels.
  • Expertise in project management and process improvement is required.
  • Strong decision-making skills, strategic thinking, agility, broad vision is required.
  • Excellent oral and written communication skills.
  • Attention to detail.
  • Expert time management for self, direct reports, and teams.
  • Ability to delegate responsibility to other medical writers.
  • Expert ability to lead and influence by example and stay focused (positive).
  • Demonstrate integrity.
  • Expert ability to motivate and develop best in class talent pipeline.
  • Demonstrated ability to collaborate internally and develop effective partnerships.
Benefits
  • medical, dental, vision, life insurance
  • short and long-term disability
  • business accident insurance
  • group legal insurance
  • consolidated retirement plan (pension)
  • savings plan (401(k))
  • long-term incentive program
  • 120 hours vacation per calendar year
  • 40 hours sick time per calendar year
  • 13 days holiday pay, including Floating Holidays
  • 40 hours work, personal and family time per calendar year
  • 480 hours parental leave
  • 240 hours bereavement leave for an immediate family member
  • 80 hours caregiver leave in a 52-week rolling period
  • 32 hours volunteer leave per calendar year
  • 80 hours Military Spouse Time-Off per calendar year
Applicant Tracking System Keywords

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

Hard Skills & Tools
clinical writingregulatory writingsafety documentationproject managementprocess improvementstrategic leadershipoperational leadershipdocument planningcontent developmentrisk mitigation
Soft Skills
decision-makingstrategic thinkingagilitycommunicationattention to detailtime managementdelegationleadershipmotivationcollaboration
Certifications
advanced degreeMastersPhDMD