Senior Analyst, Medical Writing, AI-assisted Operations
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Raritan • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $109,000 - $174,800 per year
Job Level
Senior
About the role
- Supports the Regulatory Medical Writing AI business lead in delivering the functional AI strategy, including change management support, AI quality improvements, organizing and coordinating user acceptance testing, deployment of upgrades and expansion into new document types.
- Maintains familiarity with current process for development of clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
- Assists in rollout and integration of GenAI-enabled authoring and review tools.
- Provides technical and functional support during pilots and full-scale deployments.
- Ensures alignment with regulatory standards and internal SOPs for AI-generated content.
- Supports user acceptance testing and change management activities.
- Develops and delivers training materials for end users.
- Monitors solution performance and gathers feedback for enhancements.
Requirements
- Minimum of a university/college degree in a scientific discipline is required.
- An advanced degree (eg, Masters, PhD, MD) is preferred.
- Minimum of 6 years of relevant pharmaceutical/scientific experience is required.
- Minimum of 4 years of relevant clinical/regulatory medical writing experience is required.
- Familiarity with AI/GenAI technologies and document automation tools, including prompting strategies.
- Experience with digital transformation initiatives preferred.
- Excellent oral and written communication skills.
- Attention to detail.
- Ability to function in a team environment.
- Organizes time well.
- Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
- Resolves complex problems under supervision.
- Demonstrates learning agility.
- Builds solid and productive relationships with cross-functional team members.
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))
- long-term incentive program
- 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
clinical writingregulatory writingdocument automationAI technologiesGenAIuser acceptance testingchange managementtraining developmentsolution performance monitoringfeedback gathering
Soft skills
oral communicationwritten communicationattention to detailteam collaborationtime managementleadershipproblem solvinglearning agilityrelationship buildinginitiative
Certifications
university degreeadvanced degree