Sr. Analyst, Medical Writing, AI-assisted Operations

Johnson & Johnson Innovative Medicine

About The Position

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 https://www.jnj.com 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. 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. 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. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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.
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.

Nice To Haves

Experience with digital transformation initiatives preferred.

Responsibilities

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.

Benefits

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.
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