- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction from group head and provide statistical scientific leadership for clinical trial safety data . Lead the statistical support for safety signal ... leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring...for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant within… more
- Merck & Co. (Durham, NC)
- …the Master Data team with general Material Handling Steward tasksDrive safety , quality and process enhancements throughout the supply chain - Project Management ... process efficiencies and drive enhancements in storage capabilities.Work closely with master data center of excellence (COE) and site integrated process teams (IPT)… more
- Aequor (Thousand Oaks, CA)
- …? Ability to adhere to regulatory requirements, written procedures and safety guidelines? Ability to evaluate documentation/ data according to company ... Routine analytical testing - Documenting, computing, compiling, interpreting, and entering data - Maintaining and operating specialized equipment - Initiating and /… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of ... Involves hands-on laboratory work, analytical procedure optimization, troubleshooting, and data analysis and collaboration with all process development teams to… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Ingredients (API), Chemical Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and Safety , Interpersonal ... enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact… more
- Aequor (Walkersville, MD)
- …procedures and instructions for all activities in which the team participates. Safety Responsibility Is knowledgeable and complies with all pertinent safety ... and regulations. Ensure that all team members comply with safety rules and regulations. Job Scope Works on problems...Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Contact… more
- Genmab (NJ)
- …trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data packages ... like a fit? Then we would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as… more
- Genmab (NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and… more
- Aequor (North Creek, WA)
- …(Required): Position Summary: We are seeking an experienced, highly motivated Research Associate to join our Manufacturing Science and Technology (MSAT) lab team in ... and executing experimental studies with increasing complexity (OFAT and DOE) Independent data analysis and visualization with Excel, JMP, or R with guidance from… more
- Eisai, Inc (Nutley, NJ)
- …related technical and end user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. ... your profile, we want to hear from you. The Associate Director, Clinical Programming must have expertise in addressing...and oversees JReview and SAS program development for clinical data processing, data review reports and listings.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support BDM analysis and reporting, such as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead ... R capabilities and implementations. Collaborate with CSPV to enable/effectively support safety signaling detections and across compounds safety reviews (ie,… more
- Merck & Co. (Rahway, NJ)
- …in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication ... change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and process… more
- Merck & Co. (Rahway, NJ)
- …projects as the leader of a cross-functional team.--Champion compliance and safety ; promote a culture of diversity, inclusion, and equity.Champion compliance and ... safety ; promote a culture of diversity, inclusion, and equity....processes including intensified inoculum/fed-batch and perfusion process development.Background in data science approaches related to cell culture and predictive… more
- Eisai, Inc (Exton, PA)
- …difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and ... as supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes and identifies areas of concern, arranges for remediation. Performs review of data entry convention documents, PVA reviews and SAE flow plan / data ... PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; preferredExtensive… more
- Novo Nordisk Inc. (Durham, NC)
- …& Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better practices, to include ... increasing awareness of data management standards & validation to create improvements in...tools when relevant Lead in the following of all safety & environmental requirements in the performance of duties… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director).-This role serves as a Virtual Plant Manager - responsible ... to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of contact for all… more
- Merck & Co. (North Wales, PA)
- …data steps, procedures, SAS/MACRO, SAS/GRAPH and programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic data (raw ... with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the data into analysis/modeling datasets, and… more
- Merck & Co. (Durham, NC)
- …Solutions, Business Process Improvements, Communication, Corrective Action Management, Data Management, Environmental Regulations, Environment Health and Safety ... Job DescriptionThe Associate Specialist, is a member of the Site...will be-responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC,… more
- Merck & Co. (Durham, NC)
- …with a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while ... procedures and business plan; receives guidance and oversight from Operations Associate Director and Director;Interprets client and/or customer needs and assesses… more
