- Creative Financial Staffing (Columbus, OH)
- …Sr . Accounting ManagerHybrid schedule in downtown ColumbusPosition Summary:The Senior Accounting Manager will lead all day-to-day finance operations and ... training & development as needed. Through program administration and coordination, the Senior Accounting Manager will ensure that the organization has the financial… more
- Tris Pharma (Monmouth Junction, NJ)
- …an opening in our Monmouth Junction, NJ facility for an experienced SR Director , Market Access and Trade.The Senior Director , Market Access and Trade ... Integrated Delivery Networks (IDNs), pharmaceutical wholesalers and specialty pharmacies, etc.. The Sr Director , Market Access and Trade is responsible for… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and...matter expert (SME) and act as company's representative during regulatory agency inspections and vendor audits.Ensure that a risk-based… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations ... and ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will ... supply.Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality… more
- Merck & Co. (Rahway, NJ)
- …to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, ... career.The Chemistry, Manufacturing & Controls (CMC) Pre-approval Pharm Executive Director is accountable for managing a team of CMC...of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high-quality CMC… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and ... of internal regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principle scientist in support of their assigned projects.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in ... Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior ...Director , Medical Affairs and will assist the Executive Director and Sr . Director (where… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Merck & Co. (Rahway, NJ)
- …CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other ... Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is responsible for:- Developing, maintaining, and implementing Core… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or act as main CMC Lead of ... and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential...lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr … more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and our Company's Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position As the Senior Director Supply Chain Operations and North America Demand Planning, you will ... Director , Supply Chain Operations. This position regularly interacts with the senior leadership in Pricing & Contracting, Regulatory , Marketing, Legal, IT… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ideally including time in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant therapeutic experience and proven ... areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The Director , Global eQMS Management QA GMP, reports to the Senior Director , Strategic GMP QA Operations. This individual is a member of ... the eQMS aligns with the evolving needs of the organization and regulatory requirements. Drive collaboration, alignment and awareness across Global Quality and GMP… more
