- Novo Nordisk Inc. (Plainsboro, NJ)
- …and contact volume grows. Relationships Reports to the Sr. Director, Patient Support Solution Quality/ Safety Associate Director. Interacts with colleagues within ... Patient Support Programs, Patient Safety , Quality, NNI IT and Telephony, Medical Information, Compliance,...of programs Expert in identifying and reporting adverse events, product technical complaints and other safety information… more
- Merck & Co. (Rahway, NJ)
- …investigational or marketed agents.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new ... Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expert for risk mitigation and oversees the global communication of important product safety information.Create and align processes that address global CSPV ... diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing… 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 one ... agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support .Maintain the safety and orderliness of the lab; ... staff shift and schedules aligned with required QC and manufacturing support functions.Work collaboratively with manufacturing and product development teams… 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 ... data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and completeness of all business… more
- Merck & Co. (North Wales, PA)
- …planning and global scientific content development, review of standard response document on product safety and efficacy, and when required, interact with Health ... approachReview all medical information resources and standard response documents containing product safety , tolerability and efficacy data. Interact with Health… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse ... (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical… more
- Merck & Co. (Rahway, NJ)
- …development skillsets.Demonstrated strength in delivering results on firm deadlines in support of product discovery, process development and commercial filings ... & tri-specific antibodies, and fusion proteins as well as the biopharmaceutic support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the… more
- Merck & Co. (Millsboro, DE)
- …in support of commercial antigen/antibody manufacturing and sterile biopharmaceutical product fill-finish. The BTS-SS team is also responsible for supporting the ... the improvement or acceleration of activities within the department, and also within support fields such as Environment, Health and Safety .Trains and guides… more
- Merck & Co. (Durham, NC)
- …This individual must actively manage his/her team to reliably support customer demand (including employee development, routine coaching sessions, recognition, ... in order to resolve process/equipment issues, minimize downtime, and ensure product quality.- This role actively supports, participates and embraces an inclusive… more
- Merck & Co. (Durham, NC)
- …therapies for our patients. We work in the manufacturing plants with a " Safety First, Quality Always" mindset, striving for continuous improvement, and earn our ... new facility will include end-to-end processing of drug substance, drug product , including biotech culture growth, harvest, lyophilization, product inspection,… more
- Merck & Co. (Rahway, NJ)
- …characterization such that the process is scalable without compromising stability, safety , efficacy, and delivery. During development, we leverage smart experimental ... strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- As a Sr Utilities Engineer (Clean Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. ... monitoring the existing systems with respect to quality of final product and efficiency of operation. Responsibilities will include:Strong technical skills, be… more
- Merck & Co. (Rahway, NJ)
- …of pipeline programs necessitates a need for a potential 2nd shift to support clinical supply and product development.- This position is primarily intended ... Engineer position will be responsible for providing essential technical support for processing equipment in the FLEx Oral Solid...FLEx Oral Solid Dosage (OSD) area for clinical drug product manufacturing, located in Rahway NJ. The FLEx OSD… more
- Merck & Co. (Rahway, NJ)
- …design (Drug Substance, Drug Product , Plant and Clean utilities), product equipment operation, vendor management, process safety and industry guidance ... & Development Division Scientists, Maintenance, Automation, Plant Operations, and Safety ), Engineering Firms, and Vendors to progress deliverables.The Associate… more
- Merck & Co. (Durham, NC)
- …members to develop reliable, consistent manufacturing processes that meet cGMP requirements. Support safety programs (LOTO, HECP, etc.) and environmental ... root cause, implement corrective actions, complete trending analysis, and determine product disposition.Helps establish processes that ensure required Safety … more
- Taiho Oncology (Philadelphia, PA)
- …The role of the MSL is non-promotional in nature. Responsibilities and Duties: Product /Therapeutic Area Support to External Stakeholders: Act as the primary ... a specified geography for information pertaining to disease state and Taiho's product (s) and compounds to ensure awareness and understanding. Provides high quality… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …safety and production goals are met on a daily basis.Prevent product /label mix-upsSupervise activities that support the inspection, packaging, labeling, ... leading daily Finishing personnel activities and completing associated documentation in support of producing pharmaceutical products in compliance with all safety… more
