Sr. Analyst, Medical Writing, AI‐assisted Operations
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured; where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function Medical Affairs Group
Job Sub Function Medical Writing
Job Category Professional
All Job Posting Locations
Allschwil, Basel-Country, Switzerland
Beerse, Antwerp, Belgium
High Wycombe, Buckinghamshire, United Kingdom
Raritan, New Jersey, United States of America
Spring House, Pennsylvania, United States of America
Titusville, New Jersey, United States of America
Job Description
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‐based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Sr. Analyst, Medical Writing, AI‐assisted Operations. This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.
Requisition numbers:
United States – R‐049000
Switzerland – R‐050946
United Kingdom – R‐050948
Belgium – R‐050944
Remote work may be considered on a case‐by‐case basis and if approved by the Company.
Purpose
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.
Recent experience authoring basic and complex documents within RegMW scope of work, has working knowledge of document landscape and submission dossiers. Actively participates in or leads process working groups.
Provides input into functional tactics/strategy (e.g., writing teams, process working groups).
Able to work within document management systems and familiar with workflows.
Able to troubleshoot technical issues and collaborate with IT teams.
You Will Be Responsible For
Maintains familiarity with current process for development of clinical and regulatory documents such as 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.
Maintains current knowledge of emerging AI technologies and regulatory guidance.
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.
Qualifications / Requirements
Education
Minimum of a university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, PhD, MD) is preferred.
Skills / Experience
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.
Other
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.
The expected pay range for this position is $109,000 to $174,800. The Company maintains highly competitive, performance‐based compensation programs. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
Benefits
Medical, dental, vision, life insurance, short and long‐term disability, business accident insurance and group legal insurance.
Consolidated retirement plan (pension) and savings plan (401(k)).
Long‐term incentive program.
Time off benefits:
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 in Colorado, 56 in Washington)
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 birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member (40 for an extended family member per 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
This job posting is anticipated to close on January 2, 2026. The Company may extend this period, during which the posting will remain available on https://www.careers.jnj.com.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr