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Regulatory Fda Technical Writer Jobs (NOW HIRING)

CEDENT

Technical Writer

Springfield, NJ · On-site

Solid understanding of GMP regulations (FDA, EMA, ISO, ICH, etc.) and regulatory requirements for pharmaceutical manufacturing. * Proficiency with document management systems and Microsoft Office ...

Alston

FDA Technical Consultant

Washington, DC · On-site +1

Collaborate with cross-functional teams at the Firm and at the client including legal, regulatory ... Excellent written and verbal communication skills, enabling effective interaction with various ...

Kinetic Personnel Group

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Technical Writer Deviations

Tustin, CA · On-site

$35 - $55/hr

Technical Writer - Deviation Investigations Key Responsibilities * Write, document, and maintain ... Knowledge of cGMP, FDA regulations, SOPs, CAPA, and change controls . * Experience working in ...

New

Kinetic Personnel Group

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Technical Writer Deviations

Tustin, CA · On-site

$35 - $55/hr

Technical Writer - Deviation Investigations Key Responsibilities * Write, document, and maintain ... Knowledge of cGMP, FDA regulations, SOPs, CAPA, and change controls . * Experience working in ...

New

ICONMA

Technical writer

Lake Forest, IL · On-site

Assures compliance to all regulatory standards Travel to other Company sites as needed. Skills ... Experience in technical writing and/or procedure development, preferably in FDA regulated ...

Integer

Technical Writer

Plymouth, MN · On-site

$58K - $85K/yr

Food and Drug Administration (FDA) regulations, company policies and operating procedures, and ... Researches, plans, edits, writes, and coordinates the development and edits to technical documents ...

Integer Holdings Corporation

Technical Writer

Plymouth, MN · On-site

$58K - $85K/yr

Food and Drug Administration (FDA) regulations, company policies and operating procedures, and ... Exempt Date Revised: 06-JUN-2024 Technical Writer I Integer Holdings Corporation (ITGR) is one of ...

Chitra Productions

The technical writer will conduct quality control checks to ensure compliance with Army and DoD regulations, processes, manuals, pamphlets, memoranda, guidelines, and specifications. The Technical ...

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Regulatory Fda Technical Writer information

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$13

$38

$66

How much do regulatory fda technical writer jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for regulatory fda technical writer in the United States is $38.94, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $47.12 per hour, depending on experience, location, and employer.

What is a Regulatory FDA Technical Writer?

A Regulatory FDA Technical Writer is a professional who specializes in creating and editing documents required by the U.S. Food and Drug Administration (FDA) for the approval and regulation of medical products such as drugs, medical devices, and biologics. Their responsibilities include writing, reviewing, and organizing submissions like INDs, NDAs, and 510(k)s, ensuring all documents comply with FDA guidelines and standards. They work closely with scientists, regulatory affairs teams, and subject matter experts to accurately present technical data and research findings. Their work is crucial for the successful approval and continued compliance of products within the healthcare industry.

What are the key skills and qualifications needed to thrive as a Regulatory FDA Technical Writer?

To thrive as a Regulatory FDA Technical Writer, you need a strong background in life sciences or technical fields and expertise in regulatory documentation and compliance standards. Familiarity with document management systems, regulatory submission portals (such as eCTD), and relevant FDA guidelines is essential. Exceptional written communication, attention to detail, and the ability to interpret complex scientific data are key soft skills that set candidates apart. These skills ensure the accurate, compliant, and timely submission of regulatory documents, which is crucial for successful product approvals and organizational compliance.

What are some common challenges faced by Regulatory FDA Technical Writers when preparing submission documents?

Regulatory FDA Technical Writers often face the challenge of interpreting and translating complex scientific data into clear, compliant documents that meet stringent FDA guidelines. Coordinating inputs from cross-functional teams—such as scientists, clinicians, and regulatory affairs—can also be demanding, particularly when timelines are tight. Additionally, keeping up with evolving FDA regulations and ensuring consistent document formatting and terminology are essential for successful submissions. Strong project management and communication skills are key to overcoming these challenges.

What is the difference between Regulatory Fda Technical Writer vs Regulatory Affairs Specialist?

AspectRegulatory Fda Technical WriterRegulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences or related field; certifications like RAC are commonRequires a degree in life sciences, pharmacy, or related; often holds RAC or similar certifications
Work EnvironmentFocuses on document creation, editing, and compliance documentation in regulated industriesInvolves regulatory strategy, submissions, and communication with authorities
Industry UsageUsed across pharmaceutical, biotech, and medical device companies for documentationEngaged in regulatory submissions, compliance, and product registration processes

While both roles require knowledge of FDA regulations and related certifications, Regulatory Fda Technical Writers primarily focus on preparing and editing technical documents, whereas Regulatory Affairs Specialists handle broader regulatory strategies and submissions. Both roles are essential in ensuring compliance within regulated industries.

What are popular job titles related to Regulatory Fda Technical Writer jobs?

For Regulatory Fda Technical Writer jobs, the most frequently searched job titles are:

Infographic showing various Regulatory Fda Technical Writer job openings in the United States as of September 2026, with employment types broken down into 60% Full Time, 20% Temporary, and 20% Contract. Highlights an 100% In-person job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Technical Writer

Springfield, NJ • On-site

CEDENT
IT Services • 11 - 50 employees
Learn more about CEDENTexternal

Full-time

Re-posted 21 days ago

Job description

Summary: Reporting to the appropriate department based on area of expertise (Quality Assurance, Quality Control, or Manufacturing). We are seeking a detail-oriented and highly skilled GMP Pharmaceutical Technical Writer to join our team. The ideal candidate will be responsible for creating, revising, and maintaining various controlled documentation that complies with Good Manufacturing Practices (GMP) regulations and industry standards. This role will work closely with internal and client cross-functional teams, including quality assurance, regulatory, production, and project management, to ensure timely delivery, accuracy, and clarity of all technical documents essential for the manufacturing and regulatory processes in a pharmaceutical industry.
Responsibilities:
  • Technical Documentation: Author, edit, and maintain a wide range of documents, including Standard Operating Procedures (SOPs), batch records, validation protocols, technical reports, change control documents, and regulatory submissions in accordance with GMP guidelines.
  • Compliance: Ensure all written materials meet regulatory and GMP requirements, and align with the company’s quality standards, procedures, and policies.
  • Collaboration: Work closely with both Client stakeholders and client stakeholders to establish alignment on deliverables and ensure project timelines are maintained.
  • Document Management: Assist in the management of controlled documents in document control systems (e.g., electronic document management systems), ensuring traceability, version control, and appropriate distribution of approved documents.
  • Process Improvement: Participate in process improvement initiatives related to document control, writing standards, and compliance, ensuring continuous enhancement of documentation practices.
  • Audits & Inspections: Support internal and external audits by preparing relevant documentation and ensuring that all technical writing adheres to current regulatory standards.
  • Change Control: Document and track changes in manufacturing processes, equipment, and methodologies, ensuring updates to procedures and records are properly reflected.
Essential Education and Qualifications:
  • Education: Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering, or a related field. Advanced degree or certification in technical writing is a plus.
  • Experience:
  • Minimum of 2 years of experience in technical writing within a GMP-regulated environment in the pharmaceutical, biotech, or related industry.
  • Experience writing technical documentation, including SOPs, validation protocols, and reports.
  • Knowledge:
  • Solid understanding of GMP regulations (FDA, EMA, ISO, ICH, etc.) and regulatory requirements for pharmaceutical manufacturing.
  • Proficiency with document management systems and Microsoft Office Suite (Word, Excel, PowerPoint).
  • Skills:
  • Exceptional written and verbal communication skills, with a strong ability to translate complex technical concepts into clear, concise documentation.
  • Detail-oriented with strong organizational and project management skills.
  • Ability to work independently, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment.
  • Strong analytical and problem-solving skills, with the ability to work cross-functionally across departments.
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About Cedent

Sourced by ZipRecruiter

CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008

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