Director, SDS Authoring Services 3E CompanyDirector, SDS Authoring ServicesPA8+ years of experience in SDS authoring, chemical regulatory consulting, product stewardship, or a related field, including 7+ years of leadership experience managing global teams and developing people leaders. Reporting to the Associate Vice President, Delivered Services, you will lead a global team responsible for delivering approximately 20,000 SDSs annually across a diverse portfolio of customers with varying service levels and turnaround expectations.
Technical 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.
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.
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.
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.
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.