- Organon & Co. (Jersey City, NJ)
- …assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in external professional ... **Job Description** **The Position** The Non-Clinical Safety Assessment Lead will oversee non-clinical activities and safety assessments for Organon Research and… more
- Organon & Co. (Plymouth Meeting, PA)
- …through the product lifecycle. + Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and...CMC changes, identification of global regulatory requirements and critical evaluation of… more
- Merck (West Point, PA)
- **Job Description** **Associate Principal Scientist - Device Technical and Engineering Lead (Associate Director Equivalent)** _Our company's Device Product & ... device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes. This position… more
- Insight Global (Indiana, PA)
- …software products As Director of SW Architecture - Cevego, you will lead the technical direction of the Cevego software development team globally. This role ... external partnerships and align strategies with corporate goals * Compliance & Quality: ○ Maintain adherence to regulatory standards and ensure clinically effective… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Description: Oncology Clinical Biomarker Lead (Associate/ Director ), Translational Development** Bristol Myers ... and experience working in a matrixed industrial environment. The Clinical Biomarker Lead role will be responsible for development and execution of translational… more
- Lilly (Indianapolis, IN)
- …provide modern, innovative solutions to Lilly's drug development needs. The **Senior Director Clinical Design Program Lead role** leads a cross-functional team ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...with the plan. In addition, the Clinical Design Program Lead is responsible for working with Clinical Capabilities and… more
- Astellas Pharma (Northbrook, IL)
- …and Scope:** Member of cross-functional teams, the primary purpose of the Associate Director is to act independently as Lead Safety Statistician (LSS) / ... or local project), This position may also act as Global Statistical Lead (GSTATL) for an early...data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders and HTAs. The position… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. * Advanced knowledge of regulatory ... Accountabilities: * Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for... interactions. * Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be… more
- Merck (Rahway, NJ)
- …3 DAYS PER WEEK) The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... as Business System Owner (BSO) of the current Documentum-based global submission content management solution + Co- lead ...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
- TIAA (Chicago, IL)
- The Sr. Director , Stewardship and ESG Integration Lead - Public Equities manages a team that executes on various elements of the organization's investment ... the economic interests of clients. + Develops and oversees global proxy voting polices to meet regulatory ...by our values: Champion Our People, Be Client Obsessed, Lead with Integrity, Own It, and Win As One.… more