- Novo Nordisk Inc. (West Lebanon, IN)
- …critical role in ensuring governance and continuous improvement as an enabler supporting product quality, patient safety , and data integrity, and contributes to ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...Novo Nordisk-marketed pharmaceutical productsThe Position The purpose of the Senior CSV Analyst (Remote) position is to provide subject… more
- Merck & Co. (Rahway, NJ)
- …General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research ... members of GRACS Leadership Team to provide guidance on the application of regulatory activities with cross- product or cross-functional impact, including drug… more
- Merck & Co. (Rahway, NJ)
- …products. Our team is looking for a strong candidate for the position of Senior Principal Scientist (R6) within the Biologics product development group. Primary ... Job DescriptionPosition Description: Senior Principal Scientist, Sterile and Specialty Products The...candidate should have a strong track record in biologics product development including multiple regulatory filings spanning… 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 ... Curation, Activation and Promotion - Collaborate with business partners (Marketing, Product Marketing, Field Marketing, Sales, Creative Agencies (as Needed) And… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality… more
- Merck & Co. (Durham, NC)
- …Chromatography, Homogenization, Process Monitoring, Sampling, and area cleaning . As a Senior Technician you will be an energetic leader with strong interpersonal, ... clerical functions necessary to allow proper accountability and traceability of product . - Maintains, inventories, and transports all required equipment, materials,… more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new ... product feasibility project/manufacturing support. Support updates to standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Individual Contributor Role with no direct reports. Essential Functions Establishment of the product safety profile: Develop and update the minimum mandatory ... and external stakeholders. Relationships This position will report to Senior Global Safety Lead/Director/ Senior Director...labelling for marketed products and is member of the Product Labelling Committee (PLC) Review Group Safety … more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees early-stage trials, such as global clinical development program for multiple product candidates with one or more indications; Interacts with our Discovery ... and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; Leads the… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality ... NJ facility for an experienced MD to serve as Senior Director or Director, Clinical Development. Title and salary...trial data and translates data into actionable plans at product levelContributes to Medical aspects of Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety , data, CMC, IP, patient selection, ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs, Medical Affairs and Commercial outputs ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...area to provide strategic input for the development of product strategies and liaise with external stakeholders to solicit… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs, Medical Affairs and Commercial outputs ... assigned therapeutic area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit feedback and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address ... for the investigations management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all applicable regulations… more
- Abbott (Alameda, CA)
- …issue management program. + Ensure product safety issues and product associated events are reported to regulatory agencies. + Provide regulatory ... place to work for diversity, working mothers, female executives, and scientists This ** Senior Regulatory Operations Specialist** will work out of our Alameda, CA… more
- Takeda Pharmaceuticals (Columbus, OH)
- …years regulatory and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU ... for the development and implementation of labeling content and strategy of assigned product (s) in various stages of drug development, which may include products of… more
