- Tris Pharma (Monmouth Junction, NJ)
- …or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug -device combination products ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Novo Nordisk Inc. (Boulder, CO)
- …External relationships include eg frequent interactions with NN vendors throughout the GMP drug substance and drug product manufacturing process as well as ... the development and/or implementation of processes and programs. Leverage direct manager for support on as-needed basis Physical Requirements 0-10% overnight travel… more
- Insmed Incorporated (Bridgewater, NJ)
- …development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards. The Manager must possess ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain...to the patients who need them.We're seeking an experienced Manager of Employee Relations to join us at our… more
- Merck & Co. (Rahway, NJ)
- …in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and Clinical Supply ... their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our...Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and...with internal Functions within the study team to ensure drug destruction process and other study close out activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reporting of clinical trials. preferred- Having knowledge of all phases of drug development, including early and late phase clinical development and submission ... preferred- Having solid background of applied statistics preferred- Solid knowledge of new advanced statistical methods using SAS preferred- Knowledge in database structures and set-up preferred- The candidate should have successfully provided programming… more
- Catalent (St. Petersburg, FL)
- …capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... regulatory requirements. Monitoring long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Prior work experience as a top tier management consultant, project and change manager or similar role in pharmaceutical drug development desirable. Project ... mechanisms and presentations. The successful candidate has a solid understanding of the drug development process and is skilled in the use of project management… more
- Eisai, Inc (Nutley, NJ)
- …authorities.Interface with other Eisai Departments and affiliates for dissemination of Drug Safety information, including training and orientation programs for Sales ... and Marketing, preparation and implementation of standard operating procedures, standardization of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information collection,… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Catalent (Manassas, VA)
- …help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials, ... services, and capital for the site. The Site Procurement Manager will lead site procurement team and initiate and...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal ... and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines. Facilitate successful execution and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... and External Vendors for the data services they provide to support drug development processes and global submissions.This position provides expertise within Data… more
