- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the business functions ... include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... Marketing leadership to oversee and execute all aspects of field-based programs, product theaters, & national broadcasts in conjunction with the Brand teams. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global QA. Drive a Culture ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to ... include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThis position serves in a pivotal role, leading the creation and implementation of sourcing strategies for a specific set of R&D categories (CRO, ... complex initiatives of high dollar value from inception through to implementation . Demonstrates ability to handle global projects through established interactions… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing is responsible for developing and implementing strategic marketing programs for ... and customer experiences aligned to relevant business objectives for the product . Specific job responsibilities include: designing, implementing and evaluating the… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Associate Director , HCP Marketing is responsible for developing and implementing strategic marketing programs for ... and customer experiences aligned to relevant business objectives for the product . Specific job responsibilities include: designing, implementing and evaluating the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and manage vendors and/or projects that enhance disease state and/or product knowledge, and/or selling skills. Responsibilities: Product Training Development: ... Partner with stakeholders to develop and maintain product & brand related sales training tools, workshops, and classroom presentations to ensure content is current… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team based ... it is to deliver a best-in-class high volume marketed CAR-T product . The validation scope comprises a multi-site global manufacturing network responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …whose responsibility it is to deliver a best-in-class high volume marketed CAR-T product . This effort is business critical and part of a multi-site global ... support of an expanding global manufacturing network for best-in-class CAR-T product .Work collaboratively with internal and external partners to drive global process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …privacy, legal, compliance, IT security, etc.Responsibilities- In conjunction with the Director of Data Stewardship, Cataloging and Process, develop implement a data ... strategies for cleansing and standardizing data, with a focus on eg, clinical, product , and vendor data and Identify and rectify data anomalies, inconsistencies, and… more
- Bank of America (New York, NY)
- Director , Regulatory Implementation Product Specialist New York, New York **Job Description:** At Bank of America, we are guided by a common purpose to ... pipeline, performing regulatory change impact assessments, initiating/directing regulatory implementation programs, facilitating ongoing adherence to… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director , ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be responsible for...Regulatory Affairs will be responsible for the development, implementation , and maintenance of North America regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …to assess commercial viability of potential drugs. + Provides Regulatory Implementation Risk Assessment during various phases of product development. + ... on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory… more
- S&P Global (New York, NY)
- …**Grade Level (for internal use):** 13 **_The_** **_Role:_** **_Regional Commercial Director - Regulatory Compliance_** **The Team:** This commercial position ... issues and ensure client satisfaction. + Maintain ongoing client relationships post- implementation to support future product education and adoption. **What… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called upon to ... workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with… more
