- Formation Bio (New York, NY)
- …mission to bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ... quality system, including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry… more
- Merck & Co. (Rahway, NJ)
- …inquiries from regulatory agencies to support clinical trial and commercial marketing applications. Compliance Systems : Sets a high compliance standard and ... Job DescriptionThe Executive Director for Cell Based Sciences within Analytical R&D...leaders and scientists within the Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory organizations and provides the appropriate… more
- Merck & Co. (Rahway, NJ)
- …statistical techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality ... data management and data governance.Experience developing and maintaining Building Management Systems (BMS) and Building Automation Systems (BAS), including… more
- Merck & Co. (Millsboro, DE)
- …(USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director of ... Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Executive Director (ED) for Field Medical Affairs in the US understands our Company's corporate and products/portfolio strategies and work ... and successfully in a highly matrixed environment is critical.The Executive Director provides strategic and tactical direction to the field Regional Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Excellence: Accountable to develop and execute strategies to enhance quality processes and systems organization-wide. Identify and implement ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect information, analyze… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....& Novo Nordisk (eg Investigators and site staff, Health Systems , Contract Research Organizations and Site Management Organizations etc.)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Staff members of the Medical Promotional Review team report to the Director . Works with stakeholders throughout NNI and at external agencies. Key internal… more
- Merck & Co. (Rahway, NJ)
- …results, remove barriers on portfolio or scientific prioritiesEvaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Formation Bio (New York, NY)
- …t pharmaceutical industry, with a strong understanding of cGMP regulations, quality systems , and pharmaceutical manufacturing processes. Additional experience in ... to bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …controls, quality holds, equipment on-boarding, facility expansions, and using modern quality systems such as VEEVA, LIMS, SAP. Maintain current and thorough ... regulatory agencies to drive product approvals and maintain correspondence relating to compliance efficiently and with utmost professionalism. The Director of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules ... scientific background, excellent communications skills, and project management skills to derive high- quality reference data to meet the diverse needs of the business… more
- Genmab (Plainsboro, NJ)
- …managing the key area of field force incentive compensation. The Associate Director of Field Operations - Incentive Compensation works closely with field leadership ... from design and implementation to payouts and leadership updates. The Associate Director of Field Operations - Incentive Compensation will report directly to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Merck & Co. (Rahway, NJ)
- …for traceability / lineage and make them available for business consumption; Monitor data quality report and work proactively with IT on data issues as part of daily ... like Erwin; and exposure to Windows, Linux, and Unix Operating Systems .Excellent communication, relationship and leadership skills are required.Must possess strong… more
- Genmab (Plainsboro, NJ)
- …external vendors for all aspects of program execution, tracking & reconciliations, compliance , and reporting. Daily interaction with KOLs, field force & field ... colleagues including field representation, sales operations, BIS, IT, and Compliance to ensure optimal execution. Make strategic recommendations to Sales… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and support materials for end-users, handling of queries, troubleshooting, and quality control.Lead or support consulting and implementation projects in the area ... formats, correct inaccuracies, and validate the cleansed data against defined quality metrics.Implement and manage robust data governance processes to ensure ongoing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The position will focus on maintaining House in Order by ensuring compliance with Sarbanes Oxley and Novo Nordisk Corporate Accounting guidelines in accordance ... with IFRS regulations. Relationships Reports to the Associate Director of Accounting at Novo Nordisk Inc. As part of the NNI Finance team, the manager will business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with stakeholders including, but not limited to, the Information Technology, Analytics Governance, Compliance , Field Systems and Field Force teams, as well as ... Advanced Analytics department. Primary internal relationships are within FIES, IT, Compliance , Field Systems , and other stakeholders. External relationships will… more
