- Genmab (NJ)
- …the development of new therapies by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data ... of at least one study are in scope.The Programming Manager will support the Data Management, Statistics,...establishment and maintenance of Genmab SDTM and ADaM database standards .Performs database standards consistency checks on databases… more
- Novo Nordisk Inc. (Durham, NC)
- …efforts. Identify and share better practices, to include increasing awareness of data management standards & validation to create improvements in methods, ... pathway) and with little to no guidance from the manager . Responsible for providing data -based insights as...stakeholder initiatives & projects Lead the team's Change Management standards and always manage assignments within compliance with a… more
- Genmab (NJ)
- …we would love to have you join us!The RoleThe Oncology Account Manager builds and maintains strong professional relationships with key customers and stakeholders ... and ancillary staff involved in the care of cancer patients. The Oncology Account Manager is a clinical and business leader who represents the values of Genmab by… more
- Genmab (NJ)
- …integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science through compelling clinical ... excellence. You thrive in a fast-paced environment, are motivated by high standards , and can lead projects with both independence and collaboration. You're… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... NNI Patient Safety Contracts and NNI Patient Safety/Global Patient Safety standards and processes as applicable Develops comprehensive, relevant resources (eg… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global...to track process compliance, performance and adherenceWork with the data /systems SMEs to define reporting needs to oversee process… more
- Genmab (NJ)
- …ensuring consistency of programming package with current electronic submission standards and guidelinesSupport optimization of programming processes, standards , ... next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Patient Safety Accountable for ensuring alignment with NNI PS /Global Patient Safety standards and processes as applicable Function as a Quality Point of Contact… more
- Merck & Co. (North Wales, PA)
- …Clinical Trial Management, Communication, Communication Management, Cross-Functional Teamwork, Data Analysis, Drug Development, Ethical Standards , ICH ... in key study planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site materials,… more
- Merck & Co. (Millsboro, DE)
- …Cell Cultures, cGMP Compliance, Communication, Customer Relationship Management (CRM), Data Analysis, Employee Performance Standards , Internal Customers, ... and ensure employees meet or exceed current procedures and techniquesCoordinate SAP and data base entry and the movement of finished good and in-process products… more
- Novo Nordisk Inc. (Boise, ID)
- …Influential first-line People Leader within a Region, with District Business Manager responsibility. Effectively and successfully grows and develops the people and ... key accounts, and associations. Essential Functions Ability to interpret and analyze data , generate insights and develop a business plan across multiple therapeutic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are… more
- Eisai, Inc (Nutley, NJ)
- …team in terms of application design, development, validationGood understanding in Clinical Data Management Systems & standards , eg, InForm, relational Databases, ... challenges in the programming area that connect JReview, SAS, EDC, and CDISC standards . The role will require excellent technical skills in SAS systems and… more
- Genmab (NJ)
- … transfers from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which ... discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... all RBQM deliverables. Promotes, oversees and is accountable for innovation, standards , processes and infrastructure in RBQM. Accountable for selection and oversight… more
- Merck & Co. (North Wales, PA)
- …related study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in ... Clinical Testing, Clinical Trial Compliance, Clinical Trial Management, Communication, Data Analysis, Dermatology, Drug Development, Ethical Standards , ICH… more
- Merck & Co. (Rahway, NJ)
- …with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data ... Compliance, Clinical Trial Management, Clinical Trials Analysis, Communication, Critical Thinking, Data Analysis, Drug Development, Ethical Standards , ICH GCP… more
- Repligen (Waltham, MA)
- …root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards . This role is based in Waltham, MA, and will report to the ... Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and report on monthly supplier performance data… more
- Novo Nordisk Inc. (Orlando, FL)
- …improved patient health. Internally, the EDCS reports to the Endocrinology District Business Manager of the specific sales territory. The EDCS interacts on a regular ... activity records/reports, including timely and accurate transmission of call data Participate in relevant meetings, conventions, training programs, and displays… more
- Repligen (Rancho Dominguez, CA)
- …repairs, basic/routine facility maintenance while following all safety measures. Assist manager and oversee the maintenance team. Lead projects, schedule repairs and ... during projects, new roll outs or procedures. Assist the Facilities Manager as required.Design, implement, and manage facility upgrades and renovationsSupervise… more
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