- 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 ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as...as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical ... compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing… more
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Brand Leads. Other internal relationships include Customer Experience Operations , Paid Media, Medical, Managed Markets, Corporate Communications and Public ... Affairs, Regulatory , Privacy, Sales, and Legal. Will also interact with...sites Work with NNI IT and Omnichannel Customer Experience Operations to: maintain IP configuration for new site setup… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations .The Senior Director, Clinical Operations ... clinical development portfolio. The incumbent is accountable for the Clinical Operations cross functional collaboration to develop program strategy and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums ... under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices… more
- Aequor (Thousand Oaks, CA)
- The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution ... also translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation changes for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable ... of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations … more
- Tris Pharma (Monmouth Junction, NJ)
- …throughout company (ie, QA Operations , Quality Control (QC), Manufacturing, Operations , Technical Services, Senior Leadership, etc.) on deviations and PQC ... 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)
- …GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage ... support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at… more
- Novo Nordisk Inc. (Boulder, CO)
- …overall operation. Relationships The Technical Team Lead, API Manufacturing reports to the Senior Manager , API Manufacturing. The Technical Team Lead works with ... The Technical Team Lead, API Manufacturing acts as a delegate for the Senior Manager API Manufacturing. Essential Functions Responsible for the manufacture of… more
- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior ... OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg PDMA reporting) and the systems that support these… more
- Merck & Co. (Millsboro, DE)
- …documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections ... team of animal care and testing specialists.Serve as a member of the Senior Leadership Team for the Millsboro, DE biologics manufacturing site.Lead numerous projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …new technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness ... at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently and… more
- Kolmac (Cumberland, MD)
- …in the region or center they overseeResponsible for the management of all operations of the region or center including security, scheduling, personnel, and program ... budget of the Center or Region as determined with Senior Leadership by managing a Profit and Loss StatementIn...Executive Director is responsible for ensuring that all business operations and functions carried out by Kolmac are fully… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Review is an exceptional team of highly skilled professionals within the Global Regulatory Operations (GRO) department which resides in the Regulatory ... or supervision from a more senior colleague. The GRO Quality Review Senior Manager may be assigned additional responsibilities within the department as… more
- Capital One (Mclean, VA)
- …United States of America, McLean, Virginia Senior Manager / Senior Counsel: Bankruptcy and Consumer Finance, Regulatory Capital One's growing Legal ... life balance. **The Role** As Bankruptcy and Consumer Finance Regulatory Senior Counsel on the Regulatory...operations they support. The Bankruptcy and Consumer Finance Regulatory Senior Counsel will work closely with… more
- TD Bank (New York, NY)
- …Business:** Compliance **Job Description:** **Department Overview** The Senior Compliance Manager - Credit Card Regulatory Oversight will be largely focused ... support for external regulatory exams or internal audits + Conducting regulatory research + Communicating with external examiners, senior management and… more
- Deloitte (Jersey City, NJ)
- Deloitte Risk and Financial Advisory Risk, Data and Regulatory Liquidity - Senior Manager Deloitte Risk and Financial Advisory's Financial Services Industry ... (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory ...skills. The ability to bring together stakeholders and persuade senior clients to act is essential. A genuine passion… more
