Johnson & Johnson Innovative Medicine
Sr. Analyst, Medical Writing, AI-assisted Operations
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Sr. Analyst, Medical Writing, AI-assisted Operations
Join to apply for the Sr. Analyst, Medical Writing, AI-assisted Operations role at Johnson & Johnson Innovative Medicine.
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.
Locations and Requisition Numbers
United States – Requisition Number: R‑049000
Switzerland – Requisition Number: R‑050946
United Kingdom – Requisition Number: R‑050948
Belgium – Requisition Number: R‑050944
Remote work options may be considered on a case‑by‑case basis and if approved by the Company.
Responsibilities
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, and 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.
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
Education: Minimum of a university/college degree in a scientific discipline is required. An advanced degree (Master’s, 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 is preferred.
Excellent oral and written communication skills.
Attention to detail.
Ability to function in a team environment.
Organizes time well.
Strong leadership skills in project and process management, influencing, negotiating, assertiveness, and 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 .
Benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, retirement plans, and a long‑term incentive program. Detailed benefits information is available at https://www.careers.jnj.com/employee-benefits.
This job posting is anticipated to close on January 2, 2026. The posting may remain open for additional applications if extended.
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.
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 receive your accommodation resources.
#J-18808-Ljbffr
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.
Locations and Requisition Numbers
United States – Requisition Number: R‑049000
Switzerland – Requisition Number: R‑050946
United Kingdom – Requisition Number: R‑050948
Belgium – Requisition Number: R‑050944
Remote work options may be considered on a case‑by‑case basis and if approved by the Company.
Responsibilities
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, and 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.
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
Education: Minimum of a university/college degree in a scientific discipline is required. An advanced degree (Master’s, 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 is preferred.
Excellent oral and written communication skills.
Attention to detail.
Ability to function in a team environment.
Organizes time well.
Strong leadership skills in project and process management, influencing, negotiating, assertiveness, and 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 .
Benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, retirement plans, and a long‑term incentive program. Detailed benefits information is available at https://www.careers.jnj.com/employee-benefits.
This job posting is anticipated to close on January 2, 2026. The posting may remain open for additional applications if extended.
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.
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 receive your accommodation resources.
#J-18808-Ljbffr