Hybrid Associate Director, Regulatory Medical Writing, Oncology

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About the role

  • Associate Director leading regulatory medical writing teams for oncology at Johnson & Johnson. Overseeing project strategies and managing internal teams in a medical writing capacity.

Responsibilities

  • Able to function as a lead writer on any compound independently
  • Leads in setting functional tactics/strategy
  • Leads project-level strategy (eg, submission team, global program team, clinical team)
  • Able to write and coordinate complex documents within and across TAs independently
  • Contributes to and champions internal standards, regulatory, and publishing guidelines
  • Able to lead process working groups
  • Manages a team of internal medical writers (direct reports)
  • Accountable for the quality of deliverables and compliance of direct reports

Requirements

  • Minimum of a Bachelor's Degree is required
  • An advanced degree (eg, Masters, PhD, MD) is preferred
  • Minimum of 10 years of relevant pharmaceutical/scientific experience is required
  • Minimum of 8 years of relevant clinical/regulatory medical writing experience is required
  • Experience in project management and process improvement is required
  • A minimum of 2 years of people management experience is required
  • Advanced knowledge and application of regulatory guidance documents such as ICH requirements
  • Excellent oral and written communication skills
  • Attention to detail
  • Expert time management for self, direct reports, and teams.

Benefits

  • medical
  • dental
  • vision
  • life insurance
  • short and long-term disability
  • business accident insurance
  • group legal insurance
  • retirement plan (pension)
  • savings plan (401(k))
  • vacation – 120 hours per calendar year
  • sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
  • holiday pay, including floating holidays – 13 days per calendar year
  • work, personal and family time - up to 40 hours per calendar year
  • parental leave – 480 hours within one year of the birth/adoption/foster care of a child
  • bereavement leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • caregiver leave – 80 hours in a 52-week rolling period
  • volunteer leave – 32 hours per calendar year
  • military spouse time-off – 80 hours per calendar year

Job title

Associate Director, Regulatory Medical Writing, Oncology

Job type

Experience level

Senior

Salary

$137,000 - $235,750 per year

Degree requirement

Bachelor's Degree

Location requirements

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