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Manager Biotech Technical Writer Jobs (NOW HIRING)

Management Solutions LLC

Technical Writer

Knoxville, TN · On-site

Management Solutions is seeking a Technical Writer to support delivery of mission-critical services within a federal IT environment. This role is responsible for developing, editing, and maintaining ...

Oran Inc

Technical Writer

Herndon, VA · On-site

The ideal candidate will have strong writing, documentation, and process management skills. Key Responsibilities * Develop technical, scientific, and regulatory documentation. * Create SOPs, process ...

@Orchard

Technical Writer

Fredericksburg, VA · On-site

The Technical Writer will collaborate closely with Product Management, Technical Publications Support Specialists, Graphic Illustrators, and Government stakeholders to create new technical manuals ...

Management Solutions LLC

Technical Writer

Knoxville, TN · On-site

Management Solutions is seeking a Technical Writer to support delivery of mission-critical services within a federal IT environment. This role is responsible for developing, editing, and maintaining ...

Linchpin Solutions Inc

Technical Writer

Quantico, VA · On-site

The Technical Writer supports the MOCTT Documentation Support Services mission at the Marine Corps ... Experience managing document version control, configuration, and quality assurance in an ISO 9001 ...

RWD Consulting, LLC

Technical Writer

Falls Church, VA · On-site

$110K - $115K/yr

The Technical Writer serves as the subject matter expert and focal point for technical writing support functions and assists PFPA directorates in developing, writing, editing and managing technical ...

Stem Xpert

Technical Writer

Malvern, PA

Technical Writer Location : Malvern, PA. Duration : Long Term Technical writing experience ... Epic and content management - Arbortext Epic Editor and SDL Contenta. * Word templates and macros

One Federal Solution

Technical Writer

Arlington, VA · On-site

$28.06/hr

The selected individual will assist with drafting, editing, reviewing, and managing policy directives, strategic planning documents, and other organizational materials. The Technical Writer must ...

RWD Consulting

Technical Writer

Falls Church, VA · On-site

$110K - $115K/yr

Program Management * Facilities Maintenance & Management * Certifications & Awards * Careers * Contact Us Job Openings >> Technical Writer Technical Writer Summary Title: Technical Writer ID: 2219 ...

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How much do manager biotech technical writer jobs pay per hour?

As of Jun 3, 2026, the average hourly pay for manager 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 is the difference between Manager Biotech Technical Writer vs Biotech Technical Writer?

AspectManager Biotech Technical WriterBiotech Technical Writer
ResponsibilitiesOversees writing teams, manages project timelines, ensures regulatory complianceCreates and edits scientific documents, manuals, and reports
Required SkillsLeadership, project management, advanced scientific writingStrong scientific writing, research skills, attention to detail
ExperienceTypically 5+ years, leadership experience preferred2+ years in biotech or scientific writing
Work EnvironmentTeam management, cross-department collaborationIndividual contributor, primarily office-based

The main difference is that the Manager Biotech Technical Writer leads teams and manages projects, while the Biotech Technical Writer focuses on creating scientific content. The manager role involves leadership and oversight, whereas the technical writer role emphasizes writing and research skills.

What cities are hiring for Manager Biotech Technical Writer jobs? Cities with the most Manager Biotech Technical Writer job openings:
What are the most commonly searched types of Biotech Technical Writer jobs? The most popular types of Biotech Technical Writer jobs are:
What states have the most Manager Biotech Technical Writer jobs? States with the most job openings for Manager Biotech Technical Writer jobs include:
Manager Biotech Technical Writer jobs near you

Regulatory CMC Technical Writer

SOKOL GxP Services

New Brunswick, NJ • On-site

Contractor

Medical, Retirement

Posted 21 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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