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.
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.
NewMedical Writer Position Integrated Resources, IncMedical Writer PositionCollegeville, PennsylvaniaContractorHighly organized, ability to prepare technical reports, summaries, protocols, and quantitative analysesTechnical Knowledge: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. Job DescriptionResponsibilities:Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.
NewMedical Writer Integrated Resources, IncMedical WriterCollegeville, PennsylvaniaContractorRESPONSIBILITIES:Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. Additional InformationTECHNICAL KNOWLEDGE: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.
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.
Senior Manager, Medical/Regulatory Writer Immunocore Holdings PlcSenior Manager, Medical/Regulatory WriterRadnor, PAVacancy NameSenior Manager, Medical/Regulatory Writer Vacancy NoVN831 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA, Remote, US DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Manager, Medical/Regulatory Writer will be accountable for leading and overseeing the medical and scientific regulatory writing for assigned programs to support submissions from first-in-human studies through product registration. Authoring or supervising the preparation of other regulatory documents required for Health Authority submissions, including but not limited to: Clinical Summaries (Clinical Overview, ISS/ISE, PK/PD summary, Advisory Committee Briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to Health Authority questions, etc.
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.
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.
NewProposal Writer, Sr Lockheed Martin CorpProposal Writer, SrKing of Prussia, PA$69,900–$123,280 / yearPay Rate: The annual base salary range for this position in California, Massachusetts, and New York (excluding most major metropolitan areas), Colorado, Hawaii, Illinois, Maryland, Minnesota, New Jersey, Vermont, Washington or Washington DC is $69,900 - $123,280. Description:The Proposal Writer, Sr will apply proven writing and communications skills to support the development of compelling narratives through drafting, messaging, and quality improvement across a range of proposal deliverables and special projects.
Proposal Writer Lockheed Martin CorpProposal WriterKing of Prussia, PA$85,400–$150,650 / yearDescription:The Proposal Writer will apply proven federal proposal writing, compliance, and strategic messaging expertise and strong interpersonal skills to collaborate with teams and write compelling, compliant proposals and strategic deliverables within tight turnarounds. Pay Rate: The annual base salary range for this position in California, Massachusetts, and New York (excluding most major metropolitan areas), Colorado, Hawaii, Illinois, Maryland, Minnesota, New Jersey, Vermont, Washington or Washington DC is $85,400 - $150,650.