ZipRecruiter

Log In

2

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

Pharmacy Careers

Appeals Pharmacist (Remote)

Milwaukee, WI · On-site +1

$56.50 - $68.75/hr

Excellent clinical judgment, written communication, and attention to regulatory detail. Why This ... Many roles offer hybrid or fully remote options. * Rewards: Competitive salary, comprehensive ...

Merjent

Staff Archaeologist - Remote

Milwaukee, WI · On-site +1

$72K - $94K/yr

Merjent has staff located across the United States who may choose a remote, in-office, or hybrid ... regulations related to cultural and historic preservation. * Competency in writing detailed ...

Merjent

Staff Archaeologist - Remote

Milwaukee, WI · Remote

$72K - $94K/yr

Merjent has staff located across the United States who may choose a remote, in-office, or hybrid ... regulations related to cultural and historic preservation. * Competency in writing detailed ...

next page

Showing results 1-20

All JobsRegulatory Writing JobsRemote Regulatory Writing JobsRemote Regulatory Writing Jobs in Racine, WI

Remote Regulatory Writing information

See Racine, WI salary details

$17

$37

$58

How much do remote regulatory writing jobs pay per hour?

As of Jun 9, 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
Regulatory Services Manager - NCCT (Remote)

Regulatory Services Manager - NCCT (Remote)

Advocate Aurora Health

Milwaukee, WI • Remote

$44.15 - $66.25/hr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 13 days ago

Advocate Aurora Health rating

7.6

Company rating: 7.6 out of 10

Based on 766 frontline employees who took The Breakroom Quiz

187th of 870 rated healthcare providers

Job description

Department:

85296 Wake Forest University Health Sciences - Clinical Trial Methods Center of Excellence

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

Pay Range

$44.15 - $66.25JOB SUMMARY
The Advocate Health National Center for Clinical Trials (NCCT) serves as an innovative platform to accelerate the conduct of clinical trials and the translation of scientific discoveries into meaningful improvements in patient care. NCCT provides centralized services for patient recruitment and enrollment, trial administration and follow-up, and the generation of real-world data and evidence.Under administrative review, provides overall administrative direction and coordination of Regulatory Services for NCCT clinical research, ensuring compliance with institutional, IRB, federal and other applicable regulatory requirements across a large number of clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions, HIPAA compliance and regulatory communications. Develops, implements and enforces policies, procedures and tools to support compliant and efficient research operations. Requires the use of judgment and discretion in performing the assigned duties and responsibilities. FUNCTIONS
  • Provides administrative oversight and direct leadership to regulatory staff, including hiring, training, performance management, coaching, and professional development; supports remote training and ongoing regulatory education.
  • Oversees regulatory submissions and approvals, including initial and continuing IRB reviews, amendments, reportable events, and study closures; monitors timely completion and maintenance of regulatory documentation.
  • Ensures all regulatory activities are conducted in compliance with applicable regulations and standards, including GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies, and departmental SOPs.
  • Prepares for, manages and responds to internal and external audits and inspections; leads responses to audit findings and coordinates development, implementation, and tracking of corrective and preventive action (CAPA) plans.
  • Provides oversight of multiple regulatory projects and workflows, monitoring progress against timelines and deliverables and addressing risks or barriers.
  • Allocates regulatory staff resources appropriately to support study portfolios and departmental priorities.
  • Communicates regulatory status, risks, and potential compliance issues to investigators, study teams, and leadership; escalates concerns as appropriate.
  • Monitors regulatory changes and guidance (e.g., FDA, NIH, HHS, HIPAA) and evaluates impact on clinical research operations; leads implementation of process or policy changes to maintain compliance.
  • Supports protocol development and study startup and closeout activities by advising on regulatory feasibility, documentation requirements, and transitions as funding or study status changes.
  • Establishes and maintains effective working relationships with institutional stakeholders, sponsors, IRB, and regulatory agencies to support compliant research conduct.
  • Coordinates preparation of regulatory metrics, reports and compliance analyses, identifying trends, risks, and opportunities for process improvement.
  • Participates in departmental, institutional, and external meetings or committees related to research compliance and regulatory affairs.
  • Assists leadership in implementing institutional and departmental regulatory policies and quality initiatives.
  • Manages special regulatory projects and performs other related duties as assigned.
Education, Experience and CertificationsMaster's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or, an equivalent combination of education and experience. Experience in medical/research environment preferred.SKILLS/QUALIFICATIONS:
  • Excellent verbal and written communication skills
  • Demonstrates knowledge of scientific and statistical principles
  • Ability to travel to affiliate sites, clinical sites and national meetings
  • Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices

Our CommitmenttoYou:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including:

Compensation

  • Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training

  • Premium pay such as shift, on call, and more based on a teammate's job

  • Incentive pay for select positions

  • Opportunity for annual increases based on performance

Benefits and more

  • Paid Time Off programs

  • Health and welfare benefits such as medical, dental, vision, life, andShort- and Long-Term Disability

  • Flexible Spending Accounts for eligible health care and dependent care expenses

  • Family benefits such as adoption assistance and paid parental leave

  • Defined contribution retirement plans with employer match and other financial wellness programs

  • Educational Assistance Program

Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.


About Advocate Health

Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

What Advocate Aurora Health employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Advocate Health logo

About Advocate Health

Sourced by ZipRecruiter

Advocate Healthcare, based in Oak Lawn, Illinois, United States, is a leading figure in the health care industry. Accessible via their official website, 'advocatehealth.com', this organization provides a wide variety of medical services and treatment options. Founded in 1995 through a merger of Evangelical Health Systems Corporation and Lutheran General HealthSystem, Advocate Healthcare has grown exponentially over the years. Now, it operates more than 400 sites of care, including 12 hospitals that encompass 11 acute care hospitals, the state’s largest integrated children’s network, five Level I trauma centers, and three Level II trauma centers. Upholding their values of equality, compassion, excellence, partnership and stewardship, Advocate Healthcare's mission is centered on building lifelong relationships with patients by delivering the best health outcomes and highest level of service through an integrated approach to care and wellness.

Industry

Hospitals and health care and social assistance

Company size

10,000+ Employees

Headquarters location

Charlotte, NC, US

View All Advocate Health Jobs

Apply