- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Merck & Co. (North Wales, PA)
- …Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.Participates in regulatory due ... manager . Preferred Experience and Skills: Substantial experience in regulatory affairs.Therapeutic area experience in vaccines or infectious diseases.- Experience… more
- Cambridge Health Alliance (Cambridge, MA)
- …Patient Safety, and working collaboratively with Quality and Safety leadership, the Manager , Accreditation & Regulatory Compliance leads efforts to ensure ... and Center for Medicare and Medicaid Services. In this role the Manager , Accreditation & Regulatory Compliance proactively plans, implements, coordinates and… more
- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer ... to work cross-functionally with existing Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... Responsibilities Manage the team responsible for drug product batch record review and drug product release practices.Develop positive relationships with the QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... 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)
- …research areas centered around rare diseases and immune disorders. 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
- Novo Nordisk Inc. (Boulder, CO)
- …dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is ... Regulatory , Quality Control, Supply Chain, and Clinical Write, review , and/or approve Standard Operating Procedures, specifications, regulatory filings,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and sustainability ... also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter...bodies to ensure DS Data Standards are aligned with regulatory requirements and the organizational policies and procedures. Promotes… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a growing Clinical Operations ... negotiations with clinical sites and vendors as well as budget review and forecasting Independently manage interactions with clinical monitors, data management,… more
- Aequor (Golden Valley, MN)
- …This is a hybrid role Full-Time We are seeking an experienced and motivated Project Manager to lead the refresh and update of our Supplier Code of Conduct. This role ... reflects best practices and emerging trends. Code of Conduct Review and Update: Conduct a thorough review ...to identify areas for improvement. Research industry standards and regulatory requirements to ensure the updated Code meets or… more
- Lundbeck (Walford, IA)
- …pharma. We are offering an exceptional opportunity to join Lundbeck as Medical Manager . If you're passionate about working in a collaborative environment and want to ... UK and Ireland. Your new role As our Medical Manager , you will work in alignment with the Head...scientific leadership across the organization, whilst ensuring compliance with regulatory requirements and industry standards. Some of your tasks… more
- Aequor (Thousand Oaks, CA)
- …on time. The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to ... functions.Responsibilities:Lead medium/small projects independently and work directly with Program Manager on large multi-year programs. Managing the overall program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... Identify opportunities for improvement within the customer campaigns and engagement. Review and interpret campaign/tactic data to inform adjustments on customer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...controls, and maintain permanent inspection readiness and actively support regulatory inspections. This individual will need to build strong… more
- Genmab (Plainsboro, NJ)
- …purpose.The Role & Department As a Senior Programming Associate or Programming Manager , you will be in the Statistical Programming team and Development Operations ... process by applying the appropriate measures (writing of code, review of code/deliverable).Supports submissions by ensuring programming deliverables are consistent… more
- Eurofins USA Food Testing (North Platte, NE)
- …in Europe over the past 20 years. Position Summary: The Laboratory Operations Manager receives sufficient authority from, and is accountable to, the Business Unit ... Manager or appointed designate for the successful completion of...equipment operating instructions, manuals, and required logbooks. Ensures all regulatory procedures pertaining to sample testing are followed correctly,… more
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