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 the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Spring House, Pennsylvania, 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 Medical Writer III, AI-Assisted Operations.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States- Requisition Number: R-049000

Switzerland - Requisition Number: R-050946

United Kingdom- Requisition Number: R-050948

Belgium- Requisition Number: R-050944

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Remote work options 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 (eg, 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, 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.
• 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 (eg, 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. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
  • 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 period10 days
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on January 2, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market

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 as defined 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.

 

 

Required Skills:

 

 

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)