- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional ... or existing systems in Regulatory AffairsRequired Skills5 years of Regulatory Operations experienceExtensive knowledge and experience with Microsoft Office,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (eg Protocol Amendments, ... areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence function, responsible for driving...as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Human Papilloma Virus ( HPV) Operations Manager , Training Center Durham's DS4 Operations Training Center Manager ... Responsibilities may include but are not limited to: Partnering with the Operations management team to create and execute learning strategies that support design,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the products reach the people who need them most. The Position As the Manager , Content Operations , you will support Novo Nordisk's strong commitment to its ... operational viability of the product, and anticipating future business needs. The Manager will be responsible for providing content feasibility insights to support… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory ... characterization for drug substance, drug product and reference standards. The Manager must possess a good understanding of pharmaceutical development processes from… more
- Aequor (Thousand Oaks, CA)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the...purchasing needs of 's US based spend across the Operations organization Execute e-sourcing (eRFX) for the Capital Construction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Merck & Co. (Rahway, NJ)
- …collaboration (including the CTC Clinical Trial Coordinator, CRAs and-COM Clinical Operations Manager ).-Responsible for creating and executing a local risk ... and adverse event reporting-requirements internally and externally.The CRM (Clinical Research Manager ) could be responsible for a particular study for several… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This position reports to the Director - Accelerated Efficiencies and Optimization, Strategic Operations . The Project Manager regularly works with members of CMR ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... effort will have a focus related to industry available cell therapy unit operations to be incorporated with an automation platform that integrates with MES systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data… 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 ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations of the LBRI Office of ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Merck & Co. (NE)
- …performance of animals and the people who care for them.The Territory Sales Manager - Livestock ID Infrastructure are responsible for establishing and driving the ... the overall company's Animal Health Livestock sales strategy. The Territory Sales Manager - Livestock ID Infrastructure will work alongside the cattle territory… more
- Merck & Co. (North Wales, PA)
- …study specific partners and/or vendors.Core SkillsSolid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Merck & Co. (Durham, NC)
- …and embraces an inclusive team culture including significant interaction with Operations , Quality, Automation, Technology, and other groups as required. Primary ... of inclusion, feedback and empowerment.Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.Ability to read… more
