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Biotech Technical Writer Jobs (NOW HIRING)

Experic LLC

Technical Writer - Operations

Cranbury, NJ · On-site

$80K - $110K/yr

Bachelor's degree preferred in Life Sciences, Engineering, Technical Writing, or related field; equivalent experience may be considered. * 3+ years of experience in a pharmaceutical, biotechnology ...

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How much do biotech technical writer jobs pay per hour?

As of Jul 4, 2026, the average hourly pay for biotech 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 are the common challenges faced by Biotech Technical Writers in their daily work?

Biotech Technical Writers often encounter the challenge of translating highly technical and complex scientific data into clear, concise documents for diverse audiences, including regulatory agencies and non-specialist stakeholders. They must stay up-to-date with evolving regulations and industry best practices, which can be demanding in a rapidly changing biotech landscape. Additionally, working closely with subject matter experts from research, development, and regulatory teams requires strong collaboration and communication skills to ensure accuracy and consistency. Overcoming these challenges not only sharpens your abilities but also makes you an invaluable asset within interdisciplinary biotech environments.

What are the key skills and qualifications needed to thrive in the Biotech Technical Writer position, and why are they important?

To thrive as a Biotech Technical Writer, you need a solid understanding of scientific concepts, excellent written communication skills, and often a degree in life sciences, biotechnology, or a related field. Familiarity with document management systems, scientific publishing software, and regulatory compliance guidelines such as Good Laboratory Practices (GLP) or FDA requirements is typically required. Strong attention to detail, adaptability, and the ability to collaborate with cross-functional teams are essential soft skills in this position. These competencies are crucial for effectively translating complex scientific content into clear, accurate documentation that supports research, product development, and regulatory submissions.

What is a Biotech Technical Writer job?

A Biotech Technical Writer creates clear, accurate, and concise documentation related to biotechnology, such as research reports, regulatory submissions, standard operating procedures (SOPs), and product manuals. They translate complex scientific concepts into understandable content for various audiences, including researchers, regulators, and the general public. This role requires strong writing skills, attention to detail, and knowledge of biotech terminology and industry regulations. Biotech Technical Writers often collaborate with scientists, engineers, and regulatory professionals to ensure documentation meets industry standards.

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Biotech Technical Writer jobs near you
Infographic showing various Biotech Technical Writer job openings in the United States as of June 2026, with employment types broken down into 96% Full Time, 1% Part Time, and 3% Contract. Highlights an 83% Physical, 2% Hybrid, and 15% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Regulatory CMC Technical Writer

SOKOL GxP Services

New Brunswick, NJ • On-site

Contractor

Medical, Retirement

Posted 22 days ago

Job description

SOKOL GxP Services seeking a Technical Writer and Document Specialist to support CMC documentation for a late-stage clinical cell therapy program. This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document coordination.
The Technical Writer will author and co-author scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC submissions. This includes supporting Module 2.3 and Module 3 content, coordinating source documentation, managing submission timelines, reviewing and adjudicating comments, facilitating data verification, and helping ensure consistency and clarity across the dossier.
This position requires close collaboration with Process Development, Analytical Development, Cell Therapy Technical Operations, Quality, Regulatory Sciences, CMC matrix team leaders, project management, document management, and external suppliers as needed. The ideal candidate will be detail-oriented, organized, deadline-driven, and comfortable working in a fast-paced regulatory submission environment.
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence required and occasional travel to other local New Jersey sites for larger team meetings.
Requirements
Required Qualifications:
  • Bachelor's degree required; Biology or related discipline preferred.
  • Minimum 2 years of experience in technical writing for Regulatory CMC documentation within the pharmaceutical or biotechnology industry.
  • Familiarity with eCTD structure for regulatory submissions.
  • Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
  • Cell therapy CMC experience required.
  • Familiarity with CTD Quality sections, including Module 2.3 and Module 3.
  • Understanding of source documentation requirements for regulatory submissions and how source documents connect to the authoring process.
  • Strong verbal and written communication skills.
  • Strong attention to detail, planning, organizational, and negotiating skills.
  • Demonstrated ability to deliver high-quality documentation within filing deadlines.
  • Proficiency with Microsoft Office applications, including Word, Excel, SharePoint, and PowerPoint.
  • Ability to work independently under supervision and collaborate cross-functionally with scientific, regulatory, project management, and document management teams.
  • Ability to work in a fast-paced, changing team environment and prioritize multiple tasks.

Preferred Qualifications:
  • BLA regulatory submission experience strongly preferred.
  • Experience with computer-assisted document preparation tools preferred.
  • Proficiency in compliance-ready standards for final publication preferred.
  • Experience in biotech/pharma end-to-end product development preferred.
  • Experience training others on procedures, systems access, and document management best practices preferred.

Benefits
Competitive hourly rate, $: 33.03 - 41.95 (W-2, no C2C option)
Working hours: Monday to Friday, regular business hours
Hybrid position: 50% onsite required
Location: New Brunswick, NJ
12-month contract with possibility of extension
Occasional travel to other local New Jersey sites for larger team meetings, approximately 2-3 times per year
Health insurance, holiday pay, 401(k), referral bonus program

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