- Aequor (Pearl River, LA)
- …Substance in the downstream processing (Clarification and Purification) and buffer preparation areas of the cGMP commercial manufacturing facility. Requires good ... steam-in-place of process equipment. Other duties will include the cleaning and preparation of workspaces and biosafety cabinets. The incumbent should be proficient… more
- Merck & Co. (Rahway, NJ)
- …Driving License:NoHazardous Material(s):n/aRequired Skills:Accounting, ASC 740, Budget Preparation , Corporate Tax Compliance, Detail-Oriented, Finance, Ideas ... Generator, International Tax Consulting, International Tax Planning, Preparation of Financial Reports, Relationship Building, Tax Audits, Tax Compliance, Tax Law,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, ... (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team,… more
- BioAgilytix (Durham, NC)
- …all aspects of bioanalytical studies-including project scope definition, proposal preparation , timelines, scheduling, budget, and revenue management. This role is ... aspects of bioanalytical studies including project scope definition, proposal preparation , timelines, scheduling, budget, and revenue management.Act as primary… more
- Aequor (Tampa, FL)
- …local and international tax laws. Tax Provision and Reporting Support the preparation of ASC 740 tax provisions for Latin American jurisdictions, ensuring precise ... ensure compliance and accuracy. Forecasting and Cash Flow Support the forecast preparation to determine tax payments annual estimations. Prepare and supervise tax… more
- Eisai, Inc (Exton, PA)
- …suites in a cGMP biopharmaceutical pilot plant, including scheduling of staff, preparation and close-out of documentation, manufacture of DS/ADI materials, and suite ... production schedules. Be responsible for the scheduling of staff and facility, preparation and close-out of documentation, and maintenance of the facility and… more
- Merck & Co. (Upper Gwynedd, PA)
- …in accordance with global regulations and guidances, and is-responsible for the preparation and submission of CMC dossiers for all assigned development products. ... Skills: The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated… more
- Merck & Co. (Rahway, NJ)
- …Detail-Oriented, Law Office Administration, Legal Compliance, Legal Documents Preparation , Legal Operations, Legal Research, Legal Services, Legal Strategies, ... Automation, Supplier Management, Team Leadership, Training and Development, Trial Preparation , Vendor Contract Negotiations, Vendor Management, Vendor Management Systems… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on and authors SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audits CAPA preparation ... .Case Processing Training: Identifies case processing and related CRO/vendor training needs and reviews case processing project specific training materials. Manages and coaches the PV Vendor Training Coordinator. Qualifications: Successful candidates will be… more
- Repligen (Clifton Park, NY)
- …competencyunderstanding of measuring instrumentsinspection and cleaning of partspart preparation for bagging and sealing QualificationsMust have Previous experience ... in a warehouse packaging role Medical supplies or manufacturing experience is a huge plus.Quality control or inspection experience is highly desirablePrevious experience working in a Cleanroom Environment is preferred.HS Diploma or EquivalentAbility to lift… more
- Merck & Co. (Millsboro, DE)
- …Team (IPT) up to and including Central Services, Media Preparation , and Warehouse activities.Primary Responsibilities: Supervision of facilities, equipment and ... personnel, cross train across departments including coordination of additional labor, such as temporary employees or other departmentsReview and revise processes and procedures against corporate and regulatory policies.Review production records for… more
- Aequor (East Syracuse, NY)
- …new analytical technologies and opportunities for technical advancements.Support the preparation and review of regulatory submissions related to analytical ... procedures, method development and validation, specifications, reference standards, extended characterization, and product stability/ shelf-life.Support regulatory inspections, third-party audits, and customer audits through participating in inspection… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …employee deductions, prepare and audit quarterly tax returns, assist with the preparation and reconciliation of W-2 and other related tax statements, provide ... payroll-related customer service to internal and external customers, and perform all other related duties and tasks as required or assigned.QualificationsRequires a high school diploma or equivalent and a minimum of 5 years of directly-related payroll… more
- Merck & Co. (Rahway, NJ)
- …requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for management review and ... regulatory submission.Contribute to the development, implementation, and continuous improvement of design controls processes, procedures, and tools.Enhance our Company's professional image and competitive advantage through publications, presentations, patents,… more
- Merck & Co. (Rahway, NJ)
- …Patent Analysis, Patent Applications, Patent Examination, Patent Law, Patent Preparation , Patent Prosecution, Patent Strategy {+ 4 more}-Preferred Skills:Job Posting ... End Date:08/12/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R358990 more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation : Assist with preparation of pre-submission documents and ... CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device… more
- Merck & Co. (Rahway, NJ)
- …Loan Processing, Loan Underwriting, Management Process, Mutual Fund Operations, Preparation of Financial Reports, Team Leadership-Preferred Skills:Job Posting End ... Date:08/29/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R356057 more
- Merck & Co. (Rahway, NJ)
- …and other project stakeholders. Primary Activities: PreNDA and PreBLA meeting preparation , study data standards plan, preparing questions for FDA e-data mailboxes ... (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA),Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise,Up-versioning activities to specific versions of SDTMDevelop SAS Macros and Python… more
- Aequor (Tampa, FL)
- …products. Support QC chemist to provide the method technology transfer and project preparation work, make sure the project runs on time and smoothly. Key ... Accountabilities Performs, analyzes, and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples. Perform environmental monitoring which includes water sampling and… more
- Merck & Co. (North Wales, PA)
- …site materials, system updates, investigator-meeting planning, communication plans, preparation of status update reports, study close out activities).Leads ... team for timeline management, risk identification and mitigation, issue resolution.May facilitate and collaborate with key internal/external stakeholders (eg, study team, country teams, vendors, committees) in support of clinical study objectives.Accountable… more
