- Merck & Co. (Rahway, NJ)
- …and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small ... development such as chemical reactions, work-up, and crystallizationExperience leading file authoring, validation planning and executionExperience guiding internal/external technical… more
- AUROBINDO (Dayton, OH)
- …ResponsibilitiesSenior Scientist with previous industrial experience developing and filing generic drug dosage forms (orals/liquids)Ability to develop the ... Search on assigned Projects.Thorough understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product developmentExperience… 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
- Genmab (NJ)
- …any amendments, corrections, and updates of data packagesSupport regulatory submission/ filing activitiesRequirements: Master's or PhD in a statistical discipline ... experience in dealing with Health authorities such as discussions/negotiations in filing strategiesExperience working with SDTM, ADaM, eSUB, and CDISC requirements… more
- Merck & Co. (Rahway, NJ)
- …novel innovations during drug product development to enable best science at first filing for parenteral development processes for human health while ensuing a phase ... appropriate approach during early development.The incumbent will be responsible for the recruiting, appraisal, and development of personnel under her/his supervision to their full potential. The Director selects, trains, and effectively recommends transfers,… more
- Merck & Co. (Rahway, NJ)
- …to ensure manufacturing readiness aligns with regulatory strategy and filing timelinesEducation: Bachelor's Degree in (Bio)Chemical Engineering or related discipline ... required; PhD preferred.Required Experience and Skills:20+ years of deep and broad expertise in GMP biologics drug substance and sterile drug product manufacturingExperience across multiple biologic modalities (such as recombinant proteins, monoclonal… more
- Liggett Law Group (Lubbock, TX)
- Job Title: File Clerk / Runner Location: Lubbock, TX Job Type: Full Time Company: Liggett Law Group J ob Summary: Liggett Law Group is seeking a dependable and ... organized full-time Entry-Level Legal File Clerk/ Runner to manage and maintain legal files....clerical tasks as needed Operate basic computer systems for file management Ensure timely and accurate documentation Requirements: Reliable… more
- Merck & Co. (Rahway, NJ)
- …through the development team and governance forumsAuthor and complete regulatory filing sections, and support response to questions and pre-approval inspections from ... a product development standpointStakeholder Collaboration and Communication:Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to key stakeholders and sponsors.Foster a culture… more
- Merck & Co. (Rahway, NJ)
- …large molecule products.Responsible for 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.Manage large multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.Monitors performance and… more
- Merck & Co. (North Wales, PA)
- …in design and analysis of clinical trials; Experience with regulatory filing for approval of drug/vaccine products; Prior experiences with immunology clinical ... trials design, analysis and reporting strongly preferredBARDS2020#eligibleforERPCurrent Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a… more
- Aequor (Tampa, FL)
- …documentation to support the analysis of profitability templates and defense file to sustain positions. Intercompany Transactions Prepare detailed schedules and ... perform analysis of intercompany transactions, ensuring compliance with tax regulations and company policies. Withholding Tax and Tax Treaty Compliance Execute and oversee controls to verify the correct application of tax treaties and withholding tax on… more
- BioAgilytix (Boston, MA)
- …as protective eyewear, garments, and glovesRoutine use of standard office equipment such as computers, phones, photocopiers, and filing cabinets$43 - $46 an hour ... In this role, you'll perform high-complexity patient and clinical trial testing under CLIA while ensuring specimen integrity through strict adherence to quality and safety procedures. This is a great opportunity to gain hands-on experience with disaccharide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and partner sites.Provide technical support and leadership during Agency Inspections, filing of Submissions, and IRs.Maintain global master batch record and ... documentation on the platform process description and collaborate to the global change control process and global investigations.Maintain global program project portfolio and prioritize and drive projects from inception through regulatory approval to global… more
- Genmab (NJ)
- …Attend operational and steering committee meetings, as applicableSupport regulatory submission/ filing activitiesRequirements:MS / PhD or equivalent in a statistical ... discipline with 5+ years of experience in relevant technical areaExperience in statistical analysis, modelling and simulation and adaptive trial designsExperience in working with clinical trialsPreferred experience with oncology clinical trialsProficient… more
- Twist BioScience (South San Francisco, CA)
- …NGS), visualizing the results (eg, interactive plots), and utilizing common file formats (eg, FASTA, FASTQ).Basic understanding of cloud computing, workflow ... management systems, and CI/CD pipelines.High interest in learning and contributing to developing web applications (eg, Django, React) and utilizing database management systems (eg, PostgreSQL).About Twist BioscienceTwist Bioscience synthesizes genes from… more
- Genmab (NJ)
- …consistency across trialsResponsible for keeping proper documentation and filing to eTMFProvide sponsor oversight of vendor programming activitiesSupport ... in-house production of analysis datasets, tables, figures, and listings, by writing programs and ensuring QC before formal release, for deliverablesPerform QC on SAS-code written by other Genmab colleaguesSupport submissions by ensuring consistency of… more
- BioAgilytix (San Diego, CA)
- …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
- 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
- AUROBINDO (Durham, NC)
- …company policies and federal, state, and local employment laws. File employee records while maintaining confidentiality.Support benefits enrollment, changes, and ... employee inquiries.Should be able to handle Leave of Absences (FMLA, STD, etc.), Visas and Immigration (H1B, L1, etc.), Workers Compensation claims, Unemployment Claims, etc.Committee member for all employee activities (holiday parties, picnics, etc.) and… more
- Merck & Co. (Rahway, NJ)
- …trial decision-making, regulatory requests, clinical study reports, and new drug application filing . Produce SAS data transport files and program text files for ... regulatory submission. Assure high quality and timely deliverables. Communicate and collaborate effectively with project team members.Education RequirementsMust have a master's degree in computer science, Data Science, Statistics, Applied Mathematics, Life… more
