8 Results for

Author Jobs in New Jersey

Jobs

New Brunswick, NJ30+ days ago

$40–$42 Per Hour

strong> Primary Responsibilities:

Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports.
Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.

New!

Paramus, NJ3 days ago

$45–$49 Per Hour

This role bridges drug development, manufacturing, and quality control to deliver high-quality eCTD submissions.

Key Responsibilities:.

Compliance & Risk Management:

Identify/escalate CMC regulatory risks and propose mitigation strategies.

New Brunswick, NJ30+ days ago

o Primary Responsibilities: o Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports. o Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.

New Brunswick, NJ30+ days ago

$33.03–$41.95 Per Hour

strong>Primary Responsibilities:

Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports.
Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.

New!

Raritan, NJ1 day ago

Compensation $55.00 - $55.00 / Hourly ### Hours Per Week 40 ### Number Of Positions 1 ### Job Description Summary: The purpose of this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and regulatory deliverables for drug development project teams. The scope of the role includes authoring, review, and quality assurance check of documents, and management of external medical writers.

Union, NJ30+ days ago

$45–$50

Experience authoring a variety of document types, including system design documents, project management-related plans, user guides/manuals, and training materials . Advanced skills using Microsoft Word (including creating, editing, deleting styles; track changes; and maintaining proper version control), Excel, and PowerPoint .

New Brunswick, NJ30+ days ago

$68,702–$87,256

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.

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Author Jobs in New Jersey

Technical writer Sunrise Systems Inc

Pharmaceutical CMC Writer Macpower Digital Assets Edge Private Limited

Quality - Technical writer Mindlance

Technical writer Integrated Resources, Inc

Medical Writer Oxford Global Resources, LLC

On Site Technical Writer - Union, NJ Adaptation

Regulatory CMC Technical Writer SOKOL GxP Services

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