- Aequor (Thousand Oaks, CA)
- …related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation and ... documentation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Medical Writing & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical ... and data sharing with external researchers. - The Specialist (Disclosure Medical Writer) will be primarily responsible for preparing clinical study registration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction...to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …exempt level position with responsibilities for reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and ... well as other microbiological assays.Utilize electronic systems (LIMS) for execution, documentation , review of testing.Perform tasks in a manner consistent with the… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... eTMF assist with set-up requests and Assists with filing and archiving project documentation in the eTMF within the defined timelines Performs eTMF internal reviews,… more
- BioAgilytix (Durham, NC)
- …Partner with BioAgilytix's Quality and Regulatory teams to support validation, documentation , and audit readiness for all system and integration processes. Vendor ... and Documentationo Develop and maintain comprehensive technical and user documentation , including configuration settings, customizations, troubleshooting guides, and onboarding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... across clinical study safety reporting and activities.Global Clinical Study Start-Up Documentation : Reviews all clinical study protocols to ensure consistency in… more
- Novo Nordisk Inc. (Durham, NC)
- …Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & ... Benefits including 12 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …decisions.Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities for drug products, including ... 1271 is required and 600, 601, and 610 is preferred.Experience reviewing/auditing documentation including but not limited to: Batch Records, SOPs, Work Instructions,… more
- Merck & Co. (Durham, NC)
- …ramp up of facility. Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to ... chest X-ray and TB Titer and offer extension is contingent upon passing medical results2) Position is scheduled for Monday - Friday, 6:00am - 2:30pm Operational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production data and information in a clear, concise, format according to Good Documentation Practices (GDP).Perform tasks on time in a manner consistent with quality ... schedule.Aid in the development of manufacturing processes including appropriate documentation .Drive continuous improvement of manufacturing operations leveraging own observation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge… more
- Aequor (Bothell, WA)
- …guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.Comprehensive knowledge of SOPs, cGMPs, and other compliance requirements ... working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... cross-functional teams to implement necessary security measures.8. Incident reporting and documentation : Collaborate with the Global Security & Compliance team to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... global GxP and Non-GxP computer systems.Create and review various validation documentation such as Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... CBER submissions are complete, qualify for CBER, and contain all required documentation prior to distribution to CBER Reviewers. Responsible for coordinating the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on digital channels Manages and builds relationships with internal teams; Legal, Medical and Regulatory Translates best practices for digital and corporate branding ... the digital and social media inbox Maintains process and other documentation in SharePoint Provides Google Analytics support and maintaining dashboards dedicated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... appropriate SME and follow up on the requests/escalation as needed. Process Documentation and Improvement:Support review of study documents that pertain to biosample… more
