Associate Director, Regulatory Medical Writing, Oncology
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • Pennsylvania • United States
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Salary
💰 $137,000 - $235,750 per year
Job Level
About the role
- Able to lead compound/submission/indication/disease area writing teams independently
- Directly leads or sets objectives for others on team projects and tasks
- Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy
- Establishes and drives document timelines and strategies independently
- Guides or trains cross-functional team members on processes and best practices; coaches or mentors more junior writers
- Proactively identifies and champions departmental process improvements
- Leads discussions in MW and cross-functional meetings as appropriate
- Maintains and disseminates knowledge of industry, company, and regulatory guidelines
- Supervises/manages and is accountable for direct reports
Requirements
- Minimum of a Bachelor's Degree is required
- 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
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))
- annual performance bonus
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical writingregulatory writingproject managementprocess improvementregulatory guidance documentsICH requirements
Soft Skills
leadershipcommunicationattention to detailmentoringcoaching
Certifications
Bachelor's Degree