- 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
- 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 ... other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a Hybrid work consisting of three… 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 ... other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a Hybrid work consisting of three… more
- AUROBINDO (Durham, NC)
- …welfare open enrollment, and wellness program initiatives.Assist with facilities and office management Special projects, as needed including introducing and training ... company policies and federal, state, and local employment laws. File employee records while maintaining confidentiality.Support benefits enrollment, changes, and… 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 ... other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a Hybrid work consisting of three… 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 ... other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a Hybrid work consisting of three… more
- Aequor (Tampa, FL)
- …documentation to support the analysis of profitability templates and defense file to sustain positions. Intercompany Transactions Prepare detailed schedules and ... and meeting strict deadlines in a fast-paced environment. Working Conditions: Office environment. Sitting and Standing by a Computer Key Requirements Include:… 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 ... other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a Hybrid work consisting of three… 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
- Genmab (NJ)
- …Attend operational and steering committee meetings, as applicableSupport regulatory submission/ filing activitiesRequirements:MS / PhD or equivalent in a statistical ... while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to… more
- Genmab (NJ)
- …consistency across trialsResponsible for keeping proper documentation and filing to eTMFProvide sponsor oversight of vendor programming activitiesSupport ... while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to… more
- BioAgilytix (San Diego, CA)
- …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)
- …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
- 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 ... position requires a post-offer credit check.Physical RequirementsWork is performed in an office environment. Will operate standard office equipment and will… 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 ... problems collectively.U.S. Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a Hybrid work consisting… more
- Repligen (Hopkinton, IA)
- …and update training files as necessary to maintain compliance.Copy, scan, and file records appropriately.Process requests and generates labels and batch records for ... an ISO 9001 certified Quality Management System or equivalentStrong knowledge of Microsoft Office , including Word and Excel. MS Access a plus. Ability to communicate… more
- Repligen (Rancho Dominguez, CA)
- …of ISO 9001 and GMP manufacturing standards. Proficient in SolidWorks/CAD, MS Office , and electronic file management systems. Familiarity with single-use ... systems, sterilization techniques, and lean manufacturing principles preferred. Demonstrated ability to lead cross-functional teams and manage projects in a matrixed organization. High level of personal integrity, adaptability, and leadership by example.Other… more
- Genmab (NJ)
- …submissions by ensuring that the programming-related part of the filing is consistent with current electronic submission standards and guidelines.Supports ... while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to… more
