Quality - Technical writer ECLAROQuality - Technical writerNew Brunswick, NJ$42.85–$45.45 / hourResponsibilities: 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.
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, New JerseyThis 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.
Informed Consent Writer ICON PlcInformed Consent WriterBlue Bell, PAInformed Consent Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, custo...
Senior Medical Writer (Remote) MMSSenior Medical Writer (Remote)Philadelphia, PARemoteFull timeWrite and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
Technical Writer - Operations Experic LLCTechnical Writer - OperationsCranbury, NJ$80,000–$110,000 / yearThis role will partner closely with Manufacturing, Packaging, Warehouse, Facilities, and Quality Assurance teams to draft, revise, route, and maintain controlled documentation in support of compliant GMP operations. Drafts, revises, formats, and coordinates controlled GMP documentation including: Coordinates document review, approval, and implementation activities between Operations and QA.