Manager, Regulatory Medical Writing
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Raritan • New Jersey • Pennsylvania • United States
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Salary
💰 $117,000 - $201,250 per year
About the role
- Preparing and finalizing all types of clinical documents
- Leading in a team environment
- Working with a high level of independence and taking a lead role on assigned projects
- Leading or setting objectives for others on team projects and tasks
- Guiding or training cross-functional team members on processes and best practices
- Potentially leading project-level/submission/indication writing teams
- Proactively providing recommendations for departmental process improvements
- Responsible for planning and leading the writing group for assigned program
- Actively participating in medical writing and cross-functional meetings
- Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed
Requirements
- University/college degree required
- Masters or PhD preferred
- At least 8 years of relevant pharmaceutical/scientific experience
- At least 6 years of relevant medical writing experience is required
- Attention to detail
- Excellent oral and written communication skills are pivotal to engage in cross-functional discussions
- English fluency required
- Expert project/time management skills
- Strong project/process leadership skills
- Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content
- Able to resolve complex problems independently
- Demonstrate learning agility
- Able to build and maintain solid and positive relationships with cross‐functional team members
- Solid knowledge and application of regulatory guidance documents such as ICH requirements
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))
- up to 120 hours of vacation per calendar year
- up to 40 hours of sick time per calendar year
- up to 13 days of holiday pay, including Floating Holidays
- up to 40 hours of Work, Personal and Family Time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingclinical document preparationproject managementstatistical interpretationregulatory guidanceprocess improvementdocument planningpeer reviewcontent summarizationcross-functional collaboration
Soft Skills
leadershipcommunicationattention to detailproblem-solvingmentoringcoachinglearning agilityrelationship buildingindependenceteam collaboration
Certifications
MastersPhD