- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant ... regional management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s). Manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s). Essential… more
- Lundbeck (Fresno, CA)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s). Manage… more
- Lundbeck (Waco, TX)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi...affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA , EMA) (Required)2 or more years with experience working… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …selected candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with ... role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing...and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership in developing PV goals, continued compliance, and strategy for process improvement initiatives. Qualifications: Successful candidates will be able to meet ... and Good Pharmacovigilance Procedures (GVP) required4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred4 or More Years Familiarity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference… more
- Repligen (Waltham, MA)
- …based in Waltham, MA, and will report to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and ... risks associated with supplier changes. Nonconforming Material Request (NCMR) Process and AnalysisInitiate and Document NCMRs: Identify and document nonconforming… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... user access management, training, programming support & upgrades Manage automated process for converting clinical data to standard normalized datasets which are… more
- DRT Strategies, Inc. (MD)
- …to achieve project goals and make vision a reality. Project Description: The FDA is composed of multiple Centers and Offices. Each Center/Office at FDA ... and efficiently support each Center's and Office's mission critical work. The FDA CIO's office, Office of Digital Transformation (ODT), along with the Center's… more
- Tecomet (Woburn, MA)
- …company-wide trainings on FDA and ISO requirements. + Manage the CAPA process and ensures corrective actions are established and that root cause elimination is ... **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** Senior… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced ... from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s)… more
- Lactalis American Group Inc. (Chicago, IL)
- … Engineer (Cheese, RSPC, and Powder Project Manager ) Chicago, IL (http://maps.google.com/maps?q=540+West+Madison+Street+Chicago+IL+USA+60661) * Engineering Job Type ... Process Engineer based in Chicago, IL. The Sr. Process RSPC, Cheese & Powder Project Manager ...preferred, + Minimum of 5 years of USDA or FDA regulated plant experience supporting manufacturing and utilities Specialized… more
- Kedplasma (College Park, GA)
- …developed and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory bodies, as...units. + Oversees the plasma shipments and sample submission process to ensure accuracy and timeliness of shipments. +… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** **Sr Manager , SAP CGTO Solutions Architect** **Job Overview:** We are seeking an ... CGTO & SAP SD, MM & PP modules, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP CGTO… more
