- Takeda Pharmaceuticals (Boston, MA)
- …Head, Global Regulatory Information, Data & Systems, the Head of Regulatory Data & Systems Strategy will be responsible for leading the business systems ... teams, functional SMEs, and others to identify opportunities to enhance regulatory data management + Work closely with major platform vendors to understand… more
- Takeda Pharmaceuticals (Boston, MA)
- …and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy ... possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience is responsible for developing… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **_Accountabilities:_** + The Senior Director will be responsible for complex or highly complex ... or oversees direct reports or other staff responsible. The Senior Director will lead all submission types.... requirements and strategy. + Understands and interprets scientific data as it relates to regulatory requirements… more
- Mount Sinai Health System (New York, NY)
- **Job Description** **System Senior Director , Regulatory Compliance- Mount Sinai Health System** The Senior Director for Regulatory Affairs is ... of routinely assessing the status of compliance. + Compiles data and prepares reports regarding regulatory compliance...+ Compiles data and prepares reports regarding regulatory compliance and other regulatory matters. +… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) ... regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives...objectives in the context of available and expected scientific data , regulatory guidance, and precedent. + Ensures… more
- J&J Family of Companies (Titusville, NJ)
- …best talent for a ** Senior Manager** **/Associate Director ** , ** Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) ... of America, Titusville, New Jersey, United States of America **Job Description:** ** Senior Manager/Associate Director , Regulatory Medical Writing X-TA** At… more
- J&J Family of Companies (Spring House, PA)
- …the best talent for a ** Senior Manager/Associate Director ** , ** Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) ... meetings). + Maintaining and disseminating knowledge of industry, company, and regulatory guidelines. + Interacting with senior cross-functional colleagues and… more
- Gilead Sciences, Inc. (Foster City, CA)
- … data architecture, and data engineering, for example, standardization of data per regulatory authorities (eg, ALCOA, DSAB) + Knowledge of data ... enterprise platforms. + Prioritize use cases across submission acceleration, regulatory intelligence, authoring automation, and knowledge reuse. + Translate… more
- J&J Family of Companies (Titusville, NJ)
- …clinical programs and regulatory decision-making. We are seeking a visionary Senior Director to lead Real-World Evidence (RWE) strategy and execution across ... Description:** Johnson & Johnson Innovative Medicine is recruiting for ** Senior ** ** Director , R&D Data Science...policy shaping. + Lead preparation and presentation of scientific data packages for regulatory submissions and agency… more
- Takeda Pharmaceuticals (Boston, MA)
- …and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takeda's regulatory data integrity while driving the adoption and efficiency of ... involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system...capabilities and teams. + Credibility and experience engaging at senior levels for the development and alignment of GRIDS… more