Senior Analyst, Standards Specialist

6090-Johnson & Johnson Services Inc. Legal Entity; New Brunswick (NJ); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Retirement plan

Job summary

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist, to join the Enterprise Regulatory Intelligence team within Enterprise Regulatory Compliance. You will manage revisions to enterprise quality standards, coordinate with SME stakeholders, and ensure timely publication of updates across internal systems and the standards website.

The role emphasizes governance, data integrity, and driving continuous improvements in the standards program, with a focus on leveraging AI tools under

Qualifications

• Bachelor’s degree in life sciences, quality, regulatory affairs, engineering, or related field.
• Minimum of five years of quality experience in a regulated industry (pharmaceuticals or medical devices preferred).
• Experience with controlled-document authoring, revision, and approval workflows in a regulated setting.
• Strong knowledge of GxP/medical device documentation concepts and quality systems.

Responsibilities

• Coordinate end-to-end revisions of enterprise quality standards and track change requests.
• Collaborate with SMEs and standards owners to update content.
• Route documents through the DMS for review and approval per procedures.
• Maintain the calendar for periodic reviews and ensure on-time completion of updates.
• Monitor and report program metrics (cycle time, backlog, revisions) and identify improvement opportunities.
• Support updates to standards tools and maintain traceability of references and sections.

Skills

Facilitation

Attention to detail

Program metrics

Cross-functional coordination

Written communication

Process improvements

AI literacy

Regulatory affairs

Education

Bachelor's degree in life sciences or related field

Tools

Veeva

SharePoint

Job description

Company Overview

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

Job Function

Quality

Job Sub Function

Quality Documentation

Job Category

Professional

All Job Posting Locations

Georgia (Any City), Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Toronto, Ontario, Canada

Job Description

Senior Analyst, Standards Specialist

Introduction to the Role

Johnson & J is currently seeking a Senior Analyst, Standards Specialist, to join our Enterprise Regulatory Intelligence function within J&J’s Enterprise Regulatory Compliance organization. The Standards Specialist, Senior Analyst, supports the enterprise quality standards program by coordinating and facilitating timely updates to enterprise quality standards and related tools. This role manages the day‑to‑day execution of the standards revision process by partnering with sector subject matter experts (SMEs) to incorporate approved changes, routing documents through the document management system for review and approval, and ensuring that updates are implemented according to the agreed‑upon schedule. The Senior Analyst also maintains program metrics and supports ongoing access to standards content through internal systems and the standards website.

Responsibilities/Principal Duties

• Coordinate end‑to‑end revisions of enterprise quality standards, including intake and tracking of change requests, review of change assessments for completeness and clarity, and preparation of revision packages for governance review.
• Partner with sector SMEs and standards owners to facilitate content and revision updates.
• Route standards and related documents through the document management system for review and approval, ensuring that documents are published in accordance with applicable procedures.
• Maintain the periodic review calendar and support scheduled reviews to ensure standards are reviewed and updated according to the defined program commitments.
• Maintain and report program metrics (e.g., number of revisions, cycle time, on‑time completion, backlog), identifying trends and opportunities to improve the efficiency and predictability of the standards program.
• Facilitate updates to internal regulatory standards tools by documenting the regulations or guidance that drove specific standard updates and ensuring that related references and sections are updated and traceable.
• Partner with Regulatory Intelligence managers to conduct periodic environmental scans that inform the continuous improvement of enterprise standards.
• Ensure access to standards by coordinating updates to the internal standards website so that stakeholders can easily locate current standards and supporting resources.
• Actively build AI literacy and fluency and apply approved AI tools to streamline standards program workflows (e.g., change‑request triage, drafting and editing support, and publishing coordination) while adhering to appropriate governance, privacy, and compliance requirements.
• Help to shape, and drive execution of continuous improvement projects that enhance effectiveness, value and efficiency of the enterprise quality standards program.

Qualifications

• A bachelor’s degree in life sciences, quality, regulatory affairs, engineering, or a related field is required.
• At least five years of quality experience in a regulated industry; pharmaceutical or medical device experience is preferred.
• Experience supporting controlled‑document authoring, revision, and approval workflows in a regulated environment is preferred.
• Working knowledge of quality system documentation concepts (e.g., standards, policies, SOPs) and fundamentals of GxP/medical device requirements.
• Strong facilitation and stakeholder coordination skills, with the ability to drive timelines, manage review cycles, and resolve issues in a matrixed environment.
• Excellent attention to detail and ability to ensure document consistency and traceability.
• Experience maintaining program metrics and dashboards.
• Proficiency in Excel and in analyzing trends such as cycle time, backlog, and on‑time completion.
• Proficiency in data visualization applications and a working knowledge of process automation techniques.
• Proficiency with document management systems (e.g., Veeva) and collaboration tools (e.g., SharePoint).
• Strong written communication skills, including the ability to edit controlled content and coordinate updates with technical SMEs.
• Excellent attention to detail and commitment to data integrity and accuracy.
• Ability to work independently with direction, manage deadlines, and collaborate effectively with cross‑functional partners.

Required Skills

• Business Valuations
• Coaching
• Communication
• Compliance Management
• ISO 9001
• Problem Solving
• Process Improvements
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Systems Documentation
• Regulatory Affairs Management
• Regulatory Environment
• Relationship Building
• Researching
• Standard Operating Procedure (SOP)
• Technical Writing
• Time Management

Preferred Skills

• Business Valuations
• Coaching
• Communication
• Compliance Management
• ISO 9001
• Problem Solving
• Process Improvements
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Systems Documentation
• Regulatory Affairs Management
• Regulatory Environment
• Relationship Building
• Researching
• Standard Operating Procedure (SOP)
• Technical Writing
• Time Management

Pay and Benefits

The anticipated base pay range for this position is$94,000.00-$151,800.00

• 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 a52‑week rolling period
• 10 days Volunteer Leave–32 hours per calendar year
• Military Spouse Time‑Off–80 hours per calendar year

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: ...

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

Company Overview

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/.