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Scientific Regulatory Writer Jobs (NOW HIRING)

Immunocore

The Senior Manager, Medical/Regulatory Writer will report to the Director Medical Writing and will ... The ideal candidate will have a scientific background or degree, excellent leadership skills, have ...

Novartis

Expert Regulatory Writer

Distant, PA · On-site +1

$151K - $226K/yr

Minimum university life science degree or equivalent is required. * Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. * 6 years medical writing experience or ...

Precigen, Inc

Manager, Regulatory Writing

Germantown, MD · On-site

$100K - $120K/yr

Bachelor's degree in life sciences or relevant field. * 4+ years of experience in regulatory affairs writing in the Biotech/Pharmaceutical industry. * Strong understanding of global regulatory ...

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Exponent Inc.

Scientist (Regulatory)

Washington, DC · On-site

$105K - $129K/yr

About Exponent Exponent is the only premium engineering and scientific consulting firm with the ... Excellent communication, writing, editing and proofreading skills * Excellent interpersonal skills ...

Exponent Inc.

Scientist (Regulatory)

Washington, DC · On-site

About Exponent Exponent is the only premium engineering and scientific consulting firm with the ... Excellent communication, writing, editing and proofreading skills * Excellent interpersonal skills ...

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How much do scientific regulatory writer jobs pay per hour?

As of Sep 12, 2026, the average hourly pay for scientific regulatory writer in the United States is $47.12, according to ZipRecruiter salary data. Most workers in this role earn between $33.65 and $58.65 per hour, depending on experience, location, and employer.

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Infographic showing various Scientific Regulatory Writer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 8% Part Time, and 3% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution, with an average salary of $98,010 per year, or $47.1 per hour.

Senior Scientific/Regulatory Writer

East Hanover, NJ • Remote

Novartis
Pharmaceutical and Medicine Manufacturing • 10K+ employees
Learn more about Novartisexternal

$124K - $186K/yr

Full-time

Medical, Retirement, PTO

Re-posted 26 days ago

Key responsibilities

  • Write and review high quality clinical and safety documentation for submission to regulatory authorities.

  • Lead outsourced narrative projects and coordinate related activities in RWS.

  • Participate in planning data analyses and presentation used in Clinical Study Reports (CSRs).

Novartis rating

7.8

Company rating: 7.8 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

Job description

Job Description Summary

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require minimal travel.
The Senior Regulatory Writer will be responsible for writing and reviewing high quality clinical and safety documentation for submission to regulatory authorities. Major Activities
#LI-Remote
Key Responsibilities:
1.To author and review high quality clinical and safety documents: non-registration Clinica lStudy Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).
2.Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.
3.Core member of Clinical Trial Team (CTT) / participate in Safety Management Team(SMT).
4.Actively participate in planning of data analyses and presentation used in CSRs.
5.Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
6.May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
7.Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
8.Support the development of RWS through participating in RWS workstreams and other related activities.


Job Description

Essential Requirements:

  • Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
  • ≥ 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes. Preferred
  • Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies ,key documents, approval processes, safety reporting requirements).
  • Knowledge of process for and some experience in global registering of drugs (simple submissions).
  • Excellent communication skills (written, verbal, presentations)

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Company will not sponsor visas for this position.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you


EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.


Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Salary Range

$114,100.00 - $211,900.00


Skills Desired

Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, Regulatory Compliance, Safety

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