- BioAgilytix (Boston, MA)
- …need them.BioAgilytix is seeking a detail-oriented and proactive GxP Laboratory Systems Administrator to suppport the administration , development, and deployment ... other related field, or equivalent experience4+ years' experience related to the administration , operation, and maintenance of laboratory systems such as… more
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees ... Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses … more
- Aequor (Bothell, WA)
- …have an expanding understanding of network, databases, servers, and PCs.Understanding of administration and usage of TFF systems , Nucleic Counters, Mixer, ... application periodic reviews, user access reviews, and account administration .Provide digital plant subject matter expertise (SME), to multi-function teams,… more
- Tris Pharma (Monmouth Junction, NJ)
- …regulatory packages per International Council for Harmonization (ICH)/Food and Drug Administration (FDA) guidance and provides technical guidance within and outside ... and ensures proper evaluation/trending of stability data for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA) submissionsEnsures all testing… more
- Merck & Co. (Durham, NC)
- …for the quality aspects of good manufacturing practices (GMP) computerized systems and the supporting infrastructure used in site facilities, utilities, ... regulatory expectations. Be involved in all quality-related activities for computerized systems which are required by the company manufacturing division Quality… more
- Merck & Co. (Rahway, NJ)
- …Director, Legal - Intellectual Property (IP) Technology & Operations to provide application administration and technology management support to the Intellectual ... strategic goals of the department. A successful candidate should possess prior application administration experience, strong project management skills and a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS) ... strategic vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Work with User Support… more
- Merck & Co. (Rahway, NJ)
- …process, primary packaging, compatibility characterization for processing and administration , and supporting regulatory filings.Collaborate with key stakeholders ... (i) development of sterile products for IV, IM, and/or SC route of administration (liquid and lyophilized); (ii) development of complex drug delivery systems … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the business functions of Daiichi Sankyo ... planning & definition, acquisition, design & system build, and testing phases of systems development of global informatics Systems and programs, ETL and… more
- Merck & Co. (North Wales, PA)
- …customers, including Wholesalers/Distributers, Physician Organization, Buying Groups, Health Systems , Medical Groups, Individual Health Care Provider Offices, the ... segments and commercial programs.Maintains working knowledge of promotional review systems and regulatory guidance to effectively deliver compliant assets/programs.Manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and is responsible for the ongoing production support of Commercial and R&D IT systems and applications. The individual in this role owns the support of technical ... clinical trial management system, drug labeling, and learning management system. Administration of enterprise job scheduler, Manage File Transfer, Business… more
- Eisai, Inc (Nutley, NJ)
- …and commercial requirements that govern the organization's technology systems and information assets.Purpose of role:Oversee IT compliance initiatives ... across Tokyo, US, EMEA, China ALA regions.Degree in Computer Science, Information Systems or Information Systems Management required.Minimum of 10 years'… more
- Merck & Co. (Rahway, NJ)
- …validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in ... development for both biologics and vaccines.Experience with high throughput microbioreactor systems , and advanced in situ analytics for process monitoring and… more
- Merck & Co. (Rahway, NJ)
- …interfacing with the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Operations Specialist ... Protection Analysis (LOPA)Experience with Potent Compound processing and containment systems (eg, isolators), or clean room facilities.Experience interacting with or… more
- Merck & Co. (Upper Gwynedd, PA)
- …authorities such as the United States of America Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory ... years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.Knowledge and understanding of clinical… more
- Lundbeck (Dallas, TX)
- …trends, needs, reporting and competitive developments. Oversees the business planning systems implemented by the area sales management team. Responsible for ... LundbeckPREFERRED EDUCATION, SKILLS AND EXPERIENCE: Accredited Master of Business Administration . Psychiatry product experience. 2+ years of second-line sales… more
- Merck & Co. (Rahway, NJ)
- …evidence needs of clinicians, payers, policymakers, HTA/reimbursement agencies, and health systems globally. The ability to successfully participate in and lead ... and methodological developments within therapeutic area and encourage appropriate application of new methods to outcomes research studies. -Accountable for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …initiatives. Establishes, oversees implementation, and monitors adherence to administrative policies and procedures Strategic Planning: Effectively addresses ... improvements to prepare for launch, development and/or life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to… more
- Eisai, Inc (Nutley, NJ)
- …to, routine monitoring of user access management solutions at the network, application and information layers as well as oversight of Privileged Account Management ... team to Implement and manage robust security monitoring and threat intelligence systems to detect and respond to potential security threats and vulnerabilities. This… more
- Merck & Co. (Rahway, NJ)
- …US specific V&Is and be the voice of US payers and health care systems . Responsibilities in understanding Centers for Medicare & Medicaid Services (CMS) and US ... policies, Food and Drug Administration Modernization Act ( FDAMA 114), and different US...click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity… more
