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Regulatory Writing Jobs (NOW HIRING)

Eikon Therapeutics

Senior Medical Writer I

Millbrae, CA · On-site

$125K - $136K/yr

About You You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing. What You'll Do * Independently write clinical ...

BeiGene, Inc.

Senior Principal Medical Writer

Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide. * Be able to manage multiple ...

BeiGene, Inc.

Senior Principal Medical Writer

Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide. * Be able to manage multiple ...

Synterex

Manager, FSP Medical Writing

Boston, MA · Remote

Comply with international, national, and pertinent local regulations * Adhere to SOPs and guidance ... Support Medical Writing and Business Development leadership in preparation of work orders, budgets ...

Ambition 24Hours Inc

Senior Medical Writer

The Lakes, NV · Remote

$142K - $195K/yr

Strong expertise in clinical development, regulatory writing standards, and cross-functional collaboration is essential. ───── Key Responsibilities ───── Author and edit clinical ...

MMS

Senior Medical Writer (Remote)

Jersey City, NJ · On-site

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 ...

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Zimmer, Inc.

Regulatory Affairs Specialist

Warsaw, IN · On-site

Write and manage the development of package inserts. * Review and evaluate promotion and advertising material for compliance with applicable regulations. * Review proposed product changes for impact ...

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Regulatory Writing information

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$15

$34

$145

How much do regulatory writing jobs pay per hour?

As of Jun 30, 2026, the average hourly pay for regulatory writing in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What are some common challenges faced by Regulatory Writers in the industry?

Regulatory Writers often face tight deadlines and the need to manage complex, highly detailed documents that must comply with evolving regulatory requirements. They regularly coordinate input from diverse teams such as clinical, safety, and regulatory affairs, which can pose communication and alignment challenges. Staying current with changing international regulations and ensuring absolute accuracy in submissions are other common demands. However, these challenges also make the work engaging and offer opportunities to continuously learn and develop expertise in both scientific communication and regulatory affairs.

What does a regulatory writer do?

A regulatory writer creates and prepares documentation required for regulatory submissions, such as clinical trial protocols, reports, and product labeling, ensuring compliance with industry standards and regulations. They often work closely with scientists, regulatory agencies, and quality teams, using tools like document management systems and adhering to guidelines like FDA or EMA requirements.

How much do regulatory writers make?

Regulatory writers typically earn between $70,000 and $120,000 annually, depending on experience, industry, and location. Senior roles or those with specialized knowledge in areas like pharmaceuticals or biotechnology can earn higher salaries, often exceeding $130,000. Strong writing skills, knowledge of regulatory guidelines, and familiarity with document management tools are important for this role.

What are the key skills and qualifications needed to thrive in the Regulatory Writing position, and why are they important?

To thrive in Regulatory Writing, you need expertise in scientific or medical writing, an understanding of regulatory guidelines (such as FDA, EMA, or ICH), and typically a background in life sciences or related fields. Competence with document management systems, referencing tools like EndNote, and familiarity with submission platforms are often required. Strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams are key soft skills. These skills ensure the creation of accurate, compliant, and clear regulatory documents critical for drug and device approval processes.

Are medical writers going to be replaced by AI?

Regulatory writers, including medical writers, are unlikely to be fully replaced by AI because their work requires critical thinking, understanding complex scientific data, and ensuring compliance with regulatory standards. AI tools can assist with drafting and data analysis, but human expertise remains essential for accuracy, interpretation, and ethical considerations in regulatory documentation.

What is the highest paying writing job?

In the field of regulatory writing, senior roles such as Regulatory Affairs Director or Vice President typically offer the highest salaries, often exceeding six figures annually. These positions require extensive industry experience, strong knowledge of regulations, and leadership skills, and they may involve overseeing multiple projects or teams within pharmaceutical, biotech, or medical device companies.

What is a Regulatory Writing job?

A Regulatory Writing job involves creating and reviewing documents required for regulatory submissions in industries like pharmaceuticals, biotechnology, and medical devices. Regulatory writers ensure that documents comply with guidelines from regulatory agencies such as the FDA or EMA. Their work includes clinical study reports, investigator brochures, and regulatory submission dossiers. Strong writing skills, scientific knowledge, and attention to detail are essential for this role.

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Regulatory Writing jobs near you
Senior Medical Writer I

Senior Medical Writer I

Eikon Therapeutics

Millbrae, CA • On-site

$125K - $136K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 7 days ago

Job description

Position
We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer I role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You
You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.

What You'll Do

  • Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines.
  • Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
  • Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate.
  • Help to iteratively improve medical writing processes as appropriate.
  • Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.
  • Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues.
  • Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope. 

Qualifications

  • Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing.
  • Substantial clinical study protocol writing experience desired.
  • Excellent communication, presentation, and project management skills.
  • Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines.
  • Working knowledge of statistical concepts and techniques.
  • Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
  • Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus.
  • Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
  • Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote).
  • Familiarity with concepts of structured content management preferred.
  • Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

  • 401k plan with company matching
  • Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
  • Mental health and wellness benefits
  • Weeklong summer and winter holiday shutdowns
  • Generous paid time off and holiday policies
  • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
  • Enhanced parental leave benefit
  • Daily subsidized lunch program when on-site

The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise.

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