Supports AI-driven regulatory medical writing initiatives at Johnson & Johnson. Leading project implementation and ensuring compliance with regulatory standards.
Responsibilities
Supports the Regulatory Medical Writing AI business lead in delivering the functional AI strategy.
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.
Develops and delivers training materials for end users.
Monitors solution performance and gathers feedback for enhancements.
Completes all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
Actively participates in or leads process working groups.
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.
Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
Resolve complex problems under supervision.
Demonstrates learning agility.
Builds solid and productive relationships with cross-functional team members.
Benefits
medical insurance
dental insurance
vision insurance
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
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
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
Job title
Senior Analyst, Medical Writing, AI-assisted Operations
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