- Merck & Co. (Rahway, NJ)
- …with statistical methods which are not currently available through commercial software packages . The senior programmer will be a key collaborator with statisticians, ... Implements statistical methods not currently available through commercial software packages .Experience in CDISC SDTM and ADaM standardsDemonstrated ability to work… more
- Genmab (NJ)
- …Global Drug Safety:Participate in definition, review, and approval of data packages for Data Monitoring CommitteesReview and approve any amendments, corrections, and ... updates of data packagesSupport regulatory submission/filing activitiesExperience:Master's or PhD in a statistical discipline8+ years of experience in relevant area preferred, or demonstrated capabilityExperience in statistical analysis, modelling and… more
- Merck & Co. (Rahway, NJ)
- …validation activities associated with new or upgraded instrumentation or software packages to ensure 21 CFR part 11 ComplianceSupport standardization activities for ... System Development Life CyclePrepare, review, and approve documentation such as master inventory lists, qualification documentation, calibration documentation, computer system inventories Support internal and external quality audits and maintain laboratory… more
- Merck & Co. (Rahway, NJ)
- …statistical methods not currently available through commercial software packages required.Must possess excellent communication (oral, written) skills, interpersonal ... skills and ability to negotiate and collaborate effectively; andEffective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings).Must be a project leader;… more
- Merck & Co. (Upper Gwynedd, PA)
- …execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business ... processes and systems.-Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and… more
- Aequor (Hicksville, OH)
- …documents all components discarded. Prepares shippers, inspects finished product and packages into shipper. Seals, labels, and stacks shipper. Fills cartons, ... carriers or shippers by hand with product, labels, literature or applicators. Performs cleaning tasks on machine during or after machine operation. Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety… more
- AUROBINDO (Dayton, OH)
- …generic drugs that includes more than 180 product families and 450 individual product packages . Aurobindo markets over 80% of the top 100 most prescribed products in ... the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010)Job OverviewThis is a Senior Formulation… more
- Merck & Co. (Rahway, NJ)
- …machine learning, ligand- and structure-based design) with modern software packages (eg Schrodinger, OpenEye, CCG)Experience in leading strategic scientific ... initiatives relevant to drug discoverySkilled in scientific programming (eg Python, Pipeline Pilot) and data analytics (eg Spotfire) and democratizing coding and workflowsPassion for mentoring and coaching scientific peers Preferred Experience and Skills:… more
- Genmab (NJ)
- …candidates should also have knowledge of Health Authority briefing packages , Health Authority responses, and Pediatric Investigational Plans (PIPs).Experience ... authoring clinical components of regulatory submission (NDA, BLA, MAA) highly preferred.Solid understanding of clinical development and regulatory frameworks, including GCP and ICH guidelines.Proficiency with writing tools such as MS Word, EndNote, document… more
- Genmab (NJ)
- …for the following non-comprehensive list of deliverables: IB, DSUR, briefing packages for FDA, EMA etc., supplementary in-house preparations for DMC-meetings, RP2D- ... selection preparations, supplementary material for interim analysis and final analyses (eg sub-group or other analyses not pre-defined in the SAP), answers to questions posed by regulatory authorities or ethics committees, answers to in-house questions related… more
- Deloitte (Seattle, WA)
- …for this role will end in December 2025. Work You'll Do As a Technology Packages Summer Scholar, you will play a pivotal role in helping clients maximize the value ... strategic objectives through the effective adoption and management of technology packages . Key Responsibilities + Collaborate with clients and cross-functional teams… more
- Aerotek (Janesville, WI)
- …is deeply invested in the team and equipment. Benefit from comprehensive insurance packages and a supportive work culture. **Work Environment** The position is for ... the 1st and 2nd shifts, Monday through Thursday, from 5am to 3pm OR 3pm to 1am, with optional overtime on Fridays. The shop is clean and climate-controlled, staffed by approximately 100 people. Enjoy a friendly and engaging work environment with ongoing… more
- Amazon (Seattle, WA)
- …their selection across Amazon's marketing channels. You will be responsible for developing packages for Seasonal Events, such as Valentine's Day and Easter. You will ... our key vendors and collaborate internally to bring the packages to life for our customers. The ideal candidate...with our vendors the exciting details of the CO-OP packages . 4. Partner with NASM leads to plan and… more
- Bechtel Corporation (Lake Charles, LA)
- …Summary: The Workface Planner Piping will be responsible to prepare Installation Work Packages (IWPs), Material Take-offs (MTO) & Test Work Packages (TWPs) for ... Piping Workface Planner is responsible for developing Installation work packages (IWPs), Test Work Packages (TWPs) for...developing Installation work packages (IWPs), Test Work Packages (TWPs) for Piping installations in addition to being… more
- Baker Construction (Idaho Falls, ID)
- …requirements are invoked by the quality program, this position develops work packages that are approved by project management. General work package content includes ... and generates work package documents + Gathers information needed to generate work packages from field leadership and QA/QC and works with departmental managers to… more
- Commonwealth of Pennsylvania (PA)
- …apply/testoncefor this posting. + Your results will be provided via email. Benefit packages are determined by the county and may vary. Please contact the applicable ... van or passenger car, to transport and deliver meals, packages or supplies to include loading, transporting and delivering...clients, as well as transporting program documents, supplies or packages that must be lifted, carried to vehicle, and… more
- Southern Company (Forest Park, GA)
- …"Safety First" mentality and leading by example. + Prepare high quality design packages needed to construct (new or modify existing) substations using CAD-based or ... modeling tools, based on Southern Company design standards. + Transmit drawing packages and supporting specifications into SCST Vault using the Physical Substation… more
- Marriott (Arlington, VA)
- …count accuracy. Receive, store, ship, and deliver incoming and outgoing department packages and mail. Secure the receiving room and its contents, ensuring ... safekeeping of packages . Follow all national, state, and local hazardous material...shipping guidelines and regulations. Ship all out-going mail and packages . Verify quantity and condition of packages … more
- Commonwealth of Pennsylvania (PA)
- …engineering designs including drawings, permits, plans, cost estimates, agreement packages , cost sharing requests, and project proposals to ensure completeness, ... experience reviewing engineering designs, permits, plans, cost estimates, agreement packages , cost sharing requests, AND project proposals to ensure completeness,… more
- Bechtel Corporation (Lake Charles, LA)
- …The Workface Planner E&I will be responsible to prepare Installation Work Packages (IWPs), Material Take-offs (MTO) for specific disciplines and will also support ... + The E&I Workface Planner is responsible for developing Installation work packages (IWPs) for E&I installations in addition to being accountable for developing… more
