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Remote Regulatory Writing Jobs in Racine, WI (NOW HIRING)

Deloitte

System Test and Validation Lead

Milwaukee, WI · On-site +1

Work you'll do As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk ... Effective written and verbal communication skills * Meticulous attention to detail and quality of ...

Deloitte

System Test and Validation Lead

Milwaukee, WI · On-site +1

Work you'll do As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk ... Effective written and verbal communication skills * Meticulous attention to detail and quality of ...

Deloitte

System Test and Validation Lead

Milwaukee, WI · On-site +1

Work you'll do As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk ... Effective written and verbal communication skills * Meticulous attention to detail and quality of ...

SERVE YOU RX

Compliance Analyst I

Milwaukee, WI · On-site +1

This position is open to remote. What You'll Do: As the Compliance Analyst , you will: * Research ... regulatory and compliance environment. * Clear and concise communication with strong written and ...

JLL

Environmental Site Assessor

Milwaukee, WI · On-site +1

$45K - $90K/yr

JLL - Environmental Phase I Report Writer Work Schedule: Remote + Travel, M-F 8:00 AM to 5:00 PM ... This position requires meticulous attention to detail as you compile regulatory records, historical ...

Bakertilly

Senior Payroll Consultant

Milwaukee, WI · On-site +1

... applicable laws, regulations and professional standards. Baker Tilly US, LLP is a licensed ... While this position is mostly remote, team members must be within 50 miles of a Baker Tilly office ...

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Remote Regulatory Writing information

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$17

$37

$58

How much do remote regulatory writing jobs pay per hour?

As of Jul 25, 2026, the average hourly pay for remote regulatory writing in Racine, WI is $37.10, according to ZipRecruiter salary data. Most workers in this role earn between $29.76 and $43.94 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Remote Regulatory Writer, and why are they important?

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.
What are popular job titles related to Remote Regulatory Writing jobs in Racine, WI? For Remote Regulatory Writing jobs in Racine, WI, the most frequently searched job titles are:
What cities near Racine, WI are hiring for Remote Regulatory Writing jobs? Cities near Racine, WI with the most Remote Regulatory Writing job openings:
Remote Regulatory Writing jobs near you
System Test and Validation Lead

System Test and Validation Lead

Deloitte

Milwaukee, WI • On-site, Remote

Other

Posted 5 days ago

Deloitte rating

8.1

Company rating: 8.1 out of 10

Based on 90 frontline employees who took The Breakroom Quiz

58th of 150 rated financial services

Job description

Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address emerging validation considerations for AI/ML-enabled systems and automation frameworks. If this sounds exciting, then this team may be the right fit for you!

Work you'll do

As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk, and Forensic team, you will be responsible for...

  • Lead end-to-end validation activities for GxP systems, including validation plans, IQ/OQ/PQ protocols, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
  • Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5, 21 CFR Part 11, and data integrity expectations
  • Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and responses
  • Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions
  • Validate AI/ML-enabled GxP systems and automation testing frameworks, including development of validation approaches for non-deterministic outputs and documentation of AI governance requirements

A successful candidate would possess these skills:

  • Ability to work independently and collaborate as part of a team
  • Effective written and verbal communication skills
  • Meticulous attention to detail and quality of work product
  • Ability to build and sustain professional relationships
  • Ability to lead projects or workstreams
  • Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
  • Strong interpersonal skills and professional demeanor
  • Ability to meet deadlines
  • Ability to provide clear guidance to others

The Team

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization. Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

Qualifications

Required:

  • Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
  • Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
  • Experience applying 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available principles
  • Experience managing CAPA lifecycle activities and supporting inspection readiness for Food and Drug Administration or European Medicines Agency audits
  • Experience validating AI/ML-enabled systems, distinguishing deterministic and probabilistic tool behavior, and qualifying or validating automation testing frameworks
  • Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve.
  • Limited immigration sponsorship may be available.

Preferred:

  • Experience supporting periodic review programs for validated systems and associated CAPA triggers
  • Experience validating cloud or software as a service platforms, including Veeva, ServiceNow, or Salesforce in a GxP environment
  • Experience working in Agile delivery environments with validation activities embedded in sprints
  • Experience with AI governance processes, including AI use case tracking, model risk classification, and disclosure requirements for GxP systems

For individuals assigned and/or hired to work in a remote role, Deloitte is required by law to include a reasonable estimate of the compensation range for this role. This compensation range is specific to a remote role and takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $95,000 to $145,000.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Qualifications:

Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address emerging validation considerations for AI/ML-enabled systems and automation frameworks. If this sounds exciting, then this team may be the right fit for you!

Work you'll do

As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk, and Forensic team, you will be responsible for...

  • Lead end-to-end validation activities for GxP systems, including validation plans, IQ/OQ/PQ protocols, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
  • Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5, 21 CFR Part 11, and data integrity expectations
  • Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and responses
  • Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions
  • Validate AI/ML-enabled GxP systems and automation testing frameworks, including development of validation approaches for non-deterministic outputs and documentation of AI governance requirements

A successful candidate would possess these skills:

  • Ability to work independently and collaborate as part of a team
  • Effective written and verbal communication skills
  • Meticulous attention to detail and quality of work product
  • Ability to build and sustain professional relationships
  • Ability to lead projects or workstreams
  • Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
  • Strong interpersonal skills and professional demeanor
  • Ability to meet deadlines
  • Ability to provide clear guidance to others

The Team

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization. Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

Qualifications

Required:

  • Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
  • Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices
  • Experience applying 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available principles
  • Experience managing CAPA lifecycle activities and supporting inspection readiness for Food and Drug Administration or European Medicines Agency audits
  • Experience validating AI/ML-enabled systems, distinguishing deterministic and probabilistic tool behavior, and qualifying or validating automation testing frameworks
  • Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve.
  • Limited immigration sponsorship may be available.

Preferred:

  • Experience supporting periodic review programs for validated systems and associated CAPA triggers
  • Experience validating cloud or software as a service platforms, including Veeva, ServiceNow, or Salesforce in a GxP environment
  • Experience working in Agile delivery environments with validation activities embedded in sprints
  • Experience with AI governance processes, including AI use case tracking, model risk classification, and disclosure requirements for GxP systems

For individuals assigned and/or hired to work in a remote role, Deloitte is required by law to include a reasonable estimate of the compensation range for this role. This compensation range is specific to a remote role and takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $95,000 to $145,000.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Education:Bachelor's DegreeEmployment Type:

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