Hybrid Associate Director, Regulatory Medical Writing, Oncology

at Johnson & Johnson

• Job title: Associate Director, Regulatory Medical Writing, Oncology
• Job type: Full Time
• Experience level: Senior
• Salary: $137,000 - $235,750 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Titusville, United States

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