- Merck & Co. (Rahway, NJ)
- …In this role, you will have the opportunity to leverage your expertise in regulatory systems and technologies, staying updated on regulatory changes, and ... documentation and information to meet internal and external requirements.Maintain regulatory systems and technologies to support the operational needs… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for overseeing the development, implementation, and maintenance of software systems that support business operations and objectives, with a special ... emphasis on HCP engagement systems . Requires excellent leadership skills, and a proven track...ensure they meet the needs of the business and regulatory requirements.- Collaborate with business units to identify opportunities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted ... systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted… more
- Merck & Co. (Rahway, NJ)
- …two independently entered data ("confrontation") and collaborate with Clinical Research Manager (CRM) to resolve -data entry differencesTo collaborate with CRM and ... Associates, Statisticians, Data Entry Administrators, Medical Writers, Pharmacovigilance, Auditors, Regulatory Affairs Managers and IT experts to professionally accomplish… more
- Aequor (Tallahassee, FL)
- …to MAX Shift/Schedules- Flex, normal dayshift hours Title (Role) Case Management - Manager Organization Global Patient Safety Intake Call Notes with HM: What are the ... ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their… more
- Aequor (Austin, TX)
- Remote - EST or CST time zone preferred. MANAGER IS OPENING CAP, PLEASE SUB AT MARKET RATE! CANDIDATES MUST COMPLETE THE PRESCREENING QUESTIONS FOR REVIEW ON RESUME: ... the largest project? (5) During the interview with hiring manager , you will be asked to walk through the...Category Management (GCM) teams Be the Procurement Process and Systems expert ensuring compliance with all relevant global sourcing… more
- Aequor (Thousand Oaks, CA)
- …working hour availability at the top of the resume is seeking a Supply Chain Manager to be a part of our External Planning & Delivery Pre-Commercial Supply Chain ... group. The Manager will work from Remote US Location or in...the demand/supply planning and inventory management in support of regulatory filing, clinical/commercial supply, and/or product launch and lifecycle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the pharmaceutical industry. Optimize and tune data infrastructure and systems for performance, reliability, and scalability.Qualifications: Successful candidates will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …which includes taxonomy, indexing, cataloging, archiving, metadata tagging, content management systems , etc. in Adobe Experience Manager (AEM) DAM. The ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or Global project teams. This position has advanced skills in technology systems , including word processing software and data management software, and business ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required such as organizing CAPA coordination teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiatives for his/her assigned brands, customer segments (payers or systems ), or function eg pull-through.Responsibilities- Develop and implement payer marketing ... well as marketing mix align with the Brands' goals and objectives.- Regulatory approvals: Responsible for PMRT (Product Material Review Team) PGC (Promotional Grant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a ... approval, distribution and lifecycle management of promotional marketing materials. The Manager will oversee the process across designated portions of the portfolio… more
- Eisai, Inc (Nutley, NJ)
- …and recommend appropriate technologies and platforms to accommodate evolving regulatory requirements, user needs and business and functional requirements. Lead ... the development, deployment, monitoring, maintenance, upgrade, and support of relevant systems and platforms with business and IT and stakeholders as required.… more
- Insmed Incorporated (San Diego, CA)
- …join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and ... support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …GSA, Federal, HHS and DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Essential Functions Revenue Management Systems (Contracting, Medicaid, Govt. Pricing, Chargebacks) Technologies Leadership Drive definition ... and recommend appropriate technologies and platforms to accommodate evolving regulatory requirements, user needs and business and functional requirements. Lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are ... process changes/improvement.Partner with all stakeholders to implement process improvements.Assure regulatory compliance and technical feasibility of proposed changes.Serve as… more
