ECLAROQuality - 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.
Varite, IncAEM Author Varite, IncAEM AuthorNew York, NY$48.57–$50 / hourThe AEM Author is responsible for creating, editing, managing, and publishing digital content using Adobe Experience Manager (AEM). Skills: Category Name Required Importance Experience SkillCategoryTest1_MN Digital : Adobe Experience Manager (AEM) Yes 1 >7 years
MindlanceQuality - 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.
Katalyst Healthcares & Life SciencesMedical Writer Katalyst Healthcares & Life SciencesMedical WriterParamus, NJThe ideal candidate will collaborate with cross-functional teams, including Clinical, Regulatory, Biostatistics, and Medical Affairs, to create well-structured, scientifically accurate, and regulatory-compliant documents. Collaboration & Review: Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, and quality assurance teams.
Macpower Digital Assets Edge Private LimitedPharmaceutical 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.
Sunrise Systems IncTechnical 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.
Integrated Resources, IncTechnical writer Integrated Resources, IncTechnical writerNew Brunswick, NJ$33.03–$41.95 / 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.
Pyramid ConsultingNewTechnical Writer II Pyramid ConsultingTechnical Writer IINew York, NY$50–$56 / hourKey Requirements and Technology Experience:Key skills: Regulatory submission, Technical Writer/Regulatory Writing, AuthoringCMC Regulatory AuthoringRegulatory submissionsBS/BA, MS, or PhD , from an accredited school in a science/health field (e.g., Biology, Analytical Chemistry, Pharmacy, or a related field).Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3).A background in pharmaceutical manufacturing or quality control/quality assurance is a plus. Responsibilities:The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post‑approval regulatory dossiers within pre‑established timelines.
CEDENTTechnical Writer CEDENTTechnical WriterSpringfield, NJThis role will work closely with internal and client cross-functional teams, including quality assurance, regulatory, production, and project management, to ensure timely delivery, accuracy, and clarity of all technical documents essential for the manufacturing and regulatory processes in a pharmaceutical industry. Document Management: Assist in the management of controlled documents in document control systems (e.g., electronic document management systems), ensuring traceability, version control, and appropriate distribution of approved documents.
SOKOL GxP ServicesRegulatory 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.
Heartbeat Health IncClinical Research Writer Heartbeat Health IncClinical Research WriterNY$90,000–$130,000 / yearPreferred: Experience with large healthcare datasets (EHR, claims, monitoring data) Knowledge of IRB processes and regulatory requirements Experience with digital health, virtual care, or outcomes research Prior authorship in CV journals or presentations at major cardiology conferences (ACC, AHA, HRS, ESC). Required: Advanced degree (MD, PhD, MPH, MS, or equivalent) Experience conducting clinical research or real-world evidence studies Strong statistical and data analysis skills Demonstrated experience writing and publishing peer-reviewed manuscripts Familiarity with cardiovascular clinical research preferred.
StaffingagencyrecruitmentMedical Writer StaffingagencyrecruitmentMedical WriterParamus, 07652The ideal candidate will collaborate with cross-functional teams, including Clinical, Regulatory, Biostatistics, and Medical Affairs, to create well-structured, scientifically accurate, and regulatory-compliant documents. Regulatory Document Writing:Prepare and author clinical and regulatory documents, including but not limited to:Clinical Study Protocols (CSPs) and Protocol Amendments.
AdaptationOn 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 .
MJH Healthcare Holdings LLCPrincipal Medical Writer MJH Healthcare Holdings LLCPrincipal Medical WriterNYRemote$95,000–$105,000 / yearIn addition to representing the Clinical Communications team as a content expert, the Principal Medical Writer interfaces with clients, promotional review teams, key opinion leaders, and a variety of internal professional services. • Assist writers/editors on the team in workload prioritization with deliverables and timelines of projects, prioritizing timely delivery of high-quality content.