- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit targets for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director , Data Quality and Integrity is essential in maintaining ... centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D...best approach for clinical development systems , PV systems and MA systems including data… more
- Merck & Co. (Rahway, NJ)
- …and build QMS capabilities that touch every aspect of our business processes, systems , and data .The Associate Director will collaborate and interact ... As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within Clinical ... a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition… more
- Merck & Co. (Rahway, NJ)
- …customers and patients on time, every time, across the globe.Summary, Focus and PurposeThe Director of GMP Compliance will report to the head of the Global Quality ... organization.- The responsibility of this position crosses all Human & Animal Health operating units and requires extensive partnership with manufacturing sites and… more
- Twist BioScience (South San Francisco, CA)
- …other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data flow across the biomanufacturing ecosystem. Data Integrity & Reporting: Architect and ... Director /Sr. Director , Manufacturing Execution System (MES)...the world for the better. In fields such as health care, agriculture, industrial chemicals and data … more
- Eisai, Inc (Nutley, NJ)
- …in SAS systems and application development and experience. The Associate Director must be a highly specialized individual contributor or functional manager with ... to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical Programming will… more
- Merck & Co. (Rahway, NJ)
- … health of products and reacting to signals via data driven strategies.Stakeholder Engagement and Communication:Foster strong relationships with key stakeholders, ... Job DescriptionThe Executive Director , Device Technical Operations is a pivotal leadership...improvement.-Experience with autoinjectors, prefilled syringes, and other drug delivery systems , or equivalent is required.-Key needs for this role… more
- Eisai, Inc (Exton, PA)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... 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 building a… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly compliance-driven in accordance with State and… more
- Repligen (PA)
- OverviewThe Director , Global Payroll will lead the development and execution of Repligen's global payroll strategy tosupport a growing global workforce. This role ... ready payroll processes. Reporting to the VP, Corporate Controller, the Director willcollaborate with cross-functional stakeholders including HR, Finance, Legal, and… more
- Merck & Co. (Rahway, NJ)
- …the value evidence needs of clinicians, payers, policymakers, HTA/reimbursement agencies and health systems globally. The ability to participate and lead ... closely with cross-functional teams to effectively communicate outcomes research and health economic modelling data internally and to external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to clarify positioning; lead primary care provider archetyping and segmentation; support health systems strategy by collaborating with MAPA; lead consumer demand ... Marketing & Patient Solutions team is focused on redefining health for the millions of people that can benefit...and healthcare providers. We are a group of innovative, data driven, cross-functional leaders that focusing on driving the… more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... regulatory filings (IND, MAA, BLA) Prepare for and support inspections with global health authorities (FDA, EMA, JNDA, TGA) Unite diverse internal and external teams… more
- Merck & Co. (Rahway, NJ)
- …programs.-Building Industrial Hygiene capabilities by simplifying existing and creating new systems and tools that enables our customers to adapt Industrial Hygiene ... operations.Being a change agent to ensure all changes to standards, guidelines, systems and tools achieve the desired outcome.Partner with regional and site EHS… more
- Genmab (NJ)
- …Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust ... delivery for all stages of global feasibility. Ensure standardization in use of data , tools and processes to inform risk-benefit decision making at TA, program and… more
- Repligen (Clifton Park, NY)
- …key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will play a leadership ... out/starting a new manufacturing site.Familiarity with SAP or similar ERP systems to effectively account for production and inventory.Experience in bioprocessing is… more
- Repligen (Waltham, MA)
- …risks, developing strategies, and implementing effective controls.Experience with ERP systems , financial reporting software, and compliance management tools is a ... trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …o Help measurement of KPIs to assess the success of HCP engagement strategies Health Systems Strategy o Collaborate with medical affairs and market access teams ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...to inform and execute a health systems strategy that ensures system-level acceptance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …investigations and has ability to train technicians on processes and QMS systems . Relationships Reports to: Director , Manufacturing Essential Functions Liaison ... manage multi-disciplined projects, with minimal supervision Understanding/application of quality systems Support of Health Authority inspections Possesses… more
