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
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