NewMedical Writer Integrated Resources, IncMedical WriterMadison, New JerseyContractorEnsure key messages and document style are communicated to authors and team to ensure consistency across different documentsTechnical Skill Requirements:Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy. Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents (MD deliverables).Identify resource, timeline and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management.
Quality - Technical writer MindlanceQuality - Technical writerNew Brunswick, NJo 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.
NewPharmaceutical CMC Writer Macpower Digital Assets Edge Private LimitedPharmaceutical CMC WriterParamus, NJ$45–$49 / hourThis role bridges drug development, manufacturing, and quality control to deliver high-quality eCTD submissions. Compliance & Risk Management: Identify/escalate CMC regulatory risks and propose mitigation strategies.
Medical Writer Oxford Global Resources, LLCMedical WriterRaritan, NJCompensation $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.
Regulatory CMC Technical Writer SOKOL GxP ServicesRegulatory CMC Technical WriterNew Brunswick, NJ$68,702–$87,256This 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.
NewSenior Technical Writer Fiserv IncSenior Technical WriterBerkeley Heights, NJ$60,000–$105,600 / yearYou will partner with engineers, architects, and project teams to transform complex technical implementations into clear, accurate, and actionable documentation for both operational support teams and platform engineering organizations. 3+ years of experience collaborating with infrastructure engineers, including server environments, network communications protocols, firewall security, WAN/LAN architectures, and system monitoring solutions.
NewTechnical writer Sunrise Systems IncTechnical writerNew Brunswick, NJ$40–$42 / hourPrimary 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.
On Site Technical Writer - Union, NJ AdaptationOn Site Technical Writer - Union, NJUnion, NJ$45–$50Experience 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.