Writers' Room Program Assistant tutoring students at the John D. O’Bryant School. Engaging students in writing support and development in a collaborative environment.
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
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