- Aequor (Pearl River, LA)
- Job title - File Clerk Location: Pearl River, NY 10965 Duration: 12 months contract - onsite role Work Schedule: Monday - Friday / First shift 8am - 4pm Interview - ... records stored in Pearl River, including quality checking, indexing, scanning, filing , and/or uploading documents. Prepares VRD physical records for offsite shipment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Disability processing-complex calculations, urgent off cycle payment requests, vendor file feeds, 3PSP tracking, state disability payments, workers compensation ... agencies Oversee the maintenance of payroll files and records as well as filing payroll records in personnel files (Legal Record Retention), coordination with Iron… more
- Eisai, Inc (Nutley, NJ)
- …minutes and action itemsPerforms eTMF assist with set-up requests andAssists with filing and archiving project documentation in the eTMF within the defined ... timelinesPerforms eTMF internal reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing… more
- Merck & Co. (Rahway, NJ)
- …manage questions and queries relating to VCP on a daily basis.Ensure appropriate filing of VCP related questions and documentation on the GTC's internal page.Provide ... with relevant teams.Maintain Proof of Payments records and ensure appropriate filing on internal page.Assist in the Annual US Value Reconciliation filings.Create… more
- Merck & Co. (South San Francisco, CA)
- …enable FIH translation, and compile non-clinical packages to support regulatory filing . The candidate will collaborate effectively with cross-functional partners in ... deliverables to teams.Author regulatory documents from FIH through registrational filing .Effectively partner across multidisciplinary interfaces and provide strategic DMPK… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Daiichi Sankyo standard local lab information Global Lab Analyte Mapping (GLAM) file and standard LNR worksheet template.- Models and reinforces adherence to Daiichi ... inspection readiness of laboratory data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements.-… more
- Merck & Co. (Rahway, NJ)
- …oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs ... and BLAs for the company's pipeline.Technical leadership: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …activities; assisting with month-end and year-end closing and reporting; assisting with filing a variety of tax returns and corporate reports; complete review of ... daily cash activities; contribute to the preparation for annual financial audits, including maintaining documentation for accounts payable, purchasing, and treasury and conducting internal audits; and performing all other related accounting duties as required… more
- Merck & Co. (Rahway, NJ)
- …& analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to-achieve uninterrupted ... long-term supplyLead DCT.- Critically assesses all team deliverables & fosters a learning and collaborative environment. -Prioritizes, interrogates and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines.… more
- Merck & Co. (Rahway, NJ)
- …processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to-achieve launch ... on time and uninterrupted long-term supply.Represents CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through influence, advocacy, & negotiation with an enterprise mindset.- As the CMC… more
- Merck & Co. (Rahway, NJ)
- …internal and external manufacturing sites, laboratory support for investigations, and regulatory filing activities to ensure a smooth and clear path to successful ... GMP operations and BLA filings for the company's pipeline.Leads and/or supports program-specific cell bank qualification strategies for manufacturing. Ensure project results meet requirements regarding technical quality, reliability, schedule, and cost.… more
- BioAgilytix (Durham, NC)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical Demands:Ability to work in an upright and/or stationary position ... for up to eight (8) hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent… more
- Merck & Co. (Rahway, NJ)
- …substance and/or drug product development and commercializationWorking knowledge of CMC filing requirements and regulatory guidances (eg, ICH) for drug substance ... and/or drug productExperience supporting regulatory inspections and internal audits as analytical subject matter expertExperience assisting in developing/implementing CAPA's-Strong interpersonal skills including embracing of diversity and inclusion, and… more
- Merck & Co. (Rahway, NJ)
- …experience that includes LC-MS, GC-MS and/or ICP-MS. Working knowledge of CMC filing requirements and regulatory guidance's ( eg , ICH) for API Demonstration ... of working in cross-functional team Strong interpersonal skills including the ability and sensitivity to deal with different cultures Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed… more
- BioAgilytix (Durham, NC)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical DemandsAbility to work in an upright and/or stationary position ... for up to eight (8) hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent… more
- Genmab (NJ)
- …submissions by ensuring that the programming-related part of the filing is consistent with current electronic submission standards and guidelines.Supports ... development of GenSense Dashboards by providing guidance on data structure, organization, and contents of the Genmab SDTM-databases to the Dashboard-developers and programmers.Supports resource planning and outsourcing of programming activities.Supports… more
- Merck & Co. (Rahway, NJ)
- …technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to ... successful PPQs an BLAs for our company pipeline.Advancing upstream platform process technical strategy and championing creative process improvement initiatives.Initiating new collaborations to assess new technologies and industry strategies with relevance to… more
- BioAgilytix (Durham, NC)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. Work requires minimal travel.Physical Demands Ability to work in ... an upright and/or stationary position for up to eight (8) hours per day Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment Frequent mobility needed… more
- Novo Nordisk Inc. (Boulder, CO)
- …of temperature-controlled shipments to maintain temperature requirements in transit Filing of temperature/quality events as needed Physical Requirements Travel 10%. ... Travel to other Novo Nordisk locations, storage facilities, CMO's may be required up to 10% of the time. Qualifications Bachelor's degree in Science, Business, or related discipline with five (5) years of experience in pharmaceutical or related industry… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your ... supervisor.Create/maintain spreadsheets to track other items as needed, (eg Vendor invoices).Works with Insurance Brokers to obtain study site InsuranceProvide tracking and oversight to the Vendor handling lab logistics and any other vendors deemed… more
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