- Merck & Co. (Rahway, NJ)
- …early design concept definition through commercialization to support regulatory filing , product launch, and post-market surveillance.This position will interact with ... controls and risk managementLed and managed development of DHF (design history file ) deliverables for medical devicesRecognized as a subject matter expert in at… more
- 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
- Genmab (NJ)
- …amendments, corrections, and updates of data packagesSupport regulatory submission/ filing activitiesExperience:Master's or PhD in a statistical discipline8+ years ... experience in dealing with Health authorities such as discussions/negotiations in filing strategiesExperience working with SDTM, ADaM, eSUB, and CDISC requirements… 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
- Merck & Co. (South San Francisco, CA)
- …support for programs through the worldwide marketing application filing including supportive registration documents and presentationsProvide clear, timely ... communication and interpretation of study results to therapeutic area governance, functional area experts and development review committees.Contribute to assessment of internal and external opportunities identified by Business Development and… 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
- 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)
- …in the program-specific design controls process and design history file development.Stay current with new device technologies, relevant worldwide regulations, ... standards, and effectively share this knowledge with others.Enhance our Company's professional image and competitive advantage through publications, presentations, patents, and professional activities.Education Requirements - One of the following (advanced… 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
- 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
- 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
- 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
- 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
- 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
- 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
