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Remote Regulatory Writing Jobs (NOW HIRING)

Synterex

Manager, FSP Medical Writing

Boston, MA · Remote

Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and ... Comply with international, national, and pertinent local regulations * Adhere to SOPs and guidance ...

MMS Holdings Inc.

Senior Medical Writer (Remote)

Highly proficient with styles of writing for various regulatory documents * Expert proficiency with client templates & style guides * Interact directly and independently with client to coordinate all ...

Merican

Medical Writer

Remote Shift: Mon-Fri 9.00 AM-5.00 PM * We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory ...

Olema Oncology

Lead Senior Medical Writer

Boston, MA · On-site +1

$160K - $175K/yr

Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer ... Experience working in hybrid/remote environments Attributes: * Teamwork and collaboration; balances ...

Olema Oncology

Lead Senior Medical Writer

San Francisco, CA · On-site +1

$160K - $175K/yr

Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer ... Experience working in hybrid/remote environments Attributes: * Teamwork and collaboration; balances ...

Mercor

Regulatory Counsel

New York, NY · Remote

$85 - $120/hr

Remote Commitment: 20-40 hours/week Role Responsibilities * Design realistic regulatory scenarios from your practice, such as AML/SAR preparation , OFAC screening , and FCPA assessments . * Write ...

Mercor

Regulatory Attorney - Fully Remote

New York, NY · Remote

$100 - $120/hr

Regulatory Law Expert Type: Contract Compensation: $100-$120/hour Location: Remote Role ... Strong analytical thinking and writing skills. Compensation & Legal * Transition from an hourly ...

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How much do remote regulatory writing jobs pay per hour?

As of May 29, 2026, the average hourly pay for remote regulatory writing in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 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.

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 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.

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.

More about Remote Regulatory Writing jobs
What cities are hiring for Remote Regulatory Writing jobs? Cities with the most Remote Regulatory Writing job openings:
What are the most commonly searched types of Regulatory Writing jobs? The most popular types of Regulatory Writing jobs are:
What states have the most Remote Regulatory Writing jobs? States with the most job openings for Remote Regulatory Writing jobs include:
What job categories do people searching Remote Regulatory Writing jobs look for? The top searched job categories for Remote Regulatory Writing jobs are:
Remote Regulatory Writing jobs near you
Infographic showing various Remote Regulatory Writing job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 86% Full Time, 10% Part Time, and 3% Contract. Highlights an 38% Physical, 2% Hybrid, and 60% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Medical Writing Operations Manager

Medical Writing Operations Manager

Kyverna Therapeutics

Emeryville, CA • On-site, Remote

$125K - $140K/yr

Full-time

Posted yesterday

Job description

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what's possible.

Position Summary

The Medical Writing Operations Manager will drive operational excellence and consistency across Medical Writing deliverables in support of inspection readiness and regulatory submissions. This role is responsible for document coordination and control, SOP authorship support, template maintenance, and process aid development, version management, and cross-functional alignment. The ideal candidate is detail-oriented, proactive, and highly organized, with demonstrated experience navigating regulated documentation and submission environments.

Title: Medical Writing Operations Manager

Reports to: Director of Medical Writing

Location: Emeryville, CA (Hybrid) or West Coast remote

Responsibilities
  • Support development of the Investigator's Brochure SOP and associated templates, including internal guidance documents and process aids
  • Coordinate and track CSR appendices in partnership with cross-functional teams
  • Oversee document review coordination, including preparing and aligning reviewer rosters
  • Coordinate QC activities for clinical and regulatory documents, including working with external vendors to ensure timelines and deliverables are met
  • Ensure QC-reviewed and final documents are properly archived and traceable in Veeva
  • Develop and maintain document trackers for version history, ownership, and approvals to support audit readiness
  • Support documentation and tracking activities for audit and inspection readiness, including CAPA follow-up
  • Provide coordination and process support across Medical Writing deliverables to enable consistent documentation practices and compliance
Qualifications
  • 7+ years in medical or regulatory writing operations within a GxP environment
  • Hands-on SOP authorship and routing experience, ideally with DOT or similar systems
  • Strong coordination and document control experience across review cycles, including experience with Veeva or similar regulatory document management systems
  • Experience coordinating CSR appendices and other cross-functional components of BLA submissions (e.g., Module 2 and 5 deliverables) is a plus
  • Excellent attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines
  • Strong interpersonal and communication skills, with proven ability to build trust across cross-functional teams
  • Exposure to regulatory submissions (INDs, BLAs, CTDs)
  • Well-versed in inspection-readiness documentation practices
  • Familiarity with CAPA documentation and inspection-readiness processes, including Medical Writing's role in supporting inspection responses, is a plus

The national salary range for this position is from $125K to $140K USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company's stock plan.

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