- Catalent (Harman, WV)
- …divisional strategies.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer ... Director , Supply Chain PlanningPosition Summary: Catalent Cell &...fast-paced work environment.Generous 401K match and Paid Time Off accrual. Medical , dental and vision benefits effective day one of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.- Coordinate ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product… more
- Merck & Co. (Rahway, NJ)
- …that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be ... robust scientific methodology we collaborate to discover the next medical breakthrough.Our team in Rahway, New Jersey, is seeking...of and hands-on work in applying regulatory guidance and quality standards related to product release and safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and… more
- Eisai, Inc (Nutley, NJ)
- …#LI-Remote Eisai Salary Transparency Language:The base salary range for the Associate Director , Global RWE (Real World Evidence), Global Medical Affairs - ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...we want to hear from you. Summary The Associate Director is responsible for developing RWE strategies for assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...design and execution of clinical trials, the drafting of medical / scientific documents, safety monitoring, and data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... actionable insights to guide the business. Relationships Reports to the Director , MAPA Insights. Internal relationships include close interactions with Market Access… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...organizational action, guide the Business units and the Clinical, Medical , and Regulatory Affairs (CMR) teams on strategy development… more
- Tris Pharma (Monmouth Junction, NJ)
- …stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality Assurance (QA), Pharmacovigilance, Medical Affairs, etc.) on ... facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and...regulatory teamsReviews data generated during study execution to formulate medical understanding of safety and efficacy resultsActs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation ... assessments to prioritize investigations based on potential impact on product quality , patient safety , and regulatory compliance. Address recurring deviations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- Insmed Incorporated (San Diego, CA)
- …execution of clinical studies milestones to support company budgets, and quality standards.Ensure the clinical department follows appropriate guidelines as it ... Clinical Sub-team meetings.Approves action plans to address protocol compliance, safety , data and administrative issues with investigational sites and CROs.Job… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global… more
- Catalent (St. Petersburg, FL)
- …accordance with templates and liaise with site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison between suppliers and the ... healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, ... Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality , and other affiliates.… more
