- BeOne Medicines (San Mateo, CA)
- …the impact to applicable safety documents or safety section of clinical or regulatory documents. + Support strategy development, analysis, and response to safety ... Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than 10% All qualified… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Accountabilities:** + Leads development and execution of multi-year global medical strategy for the nephrology indications and LCM of TAK-279 (mezagtiamab) and ... other pipeline assets, appropriately aligned with overall assets strategy and GPT, incorporating various functional strategies across functions in R&D and Global… more
- Takeda Pharmaceuticals (Boston, MA)
- …publications best practices and the development of scientific communications strategy and deliverables, the **Associate Director, Scientific Communications Lead, ... providing guidance and training to Publications department colleagues on publication strategy development and tactical execution best practices. This individual will… more
- VTI Life Sciences (Raleigh, NC)
- …and ambitious engineers looking to accelerate their career in the pharmaceutical , biotechnology and medical device industries. We offer an opportunity to ... Cleaning Validation Engineers to work onsite at our client's pharmaceutical manufacturing facility in the Raleigh, NC area. Job...to cycle development and hold times + Document a strategy for how CV will be executed at the… more
- AbbVie (San Francisco, CA)
- …activities, generation and dissemination of data supporting the overall scientific strategy . + Responsible from Medical Affairs for the design, analysis, ... scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for oversight… more
- Sanofi Group (Orlando, FL)
- …and controversial opinions vs; corporate policy decisions ensuring KOL relationships/medical strategy are not negatively impacted. + Ensures regulatory ... while maintaining full compliance with relevant company, industry, legal and regulatory requirements + Demonstrate operational understanding and risk management by… more
- Lilly (Indianapolis, IN)
- …supports the design, development, and commercialization of drug products and pharmaceutical delivery systems including medical devices and packaging systems. The ... users' needs and intended uses. This business enables almost $4.0 billion in pharmaceutical sales and continues to grow. DDCS supports the design, development, and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …for various management committees. + Lead the development and implementation of US regulatory strategy within a global context, providing US regulatory ... strategic considerations for expedited regulatory pathways and contribute to the Global Regulatory Strategy Document and draft CCDS. + Provide US guidance to… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …(CDx, IVD, etc.) within Regeneron's drug development pipeline in partnership with Diagnostic Strategy Leads and IVD Regulatory Affairs. This is a leadership role ... lead and partner cross-functionally within the Diagnostics team, Precision Medicine Strategy , Laboratory Operations, to directly lead and/or lead resources with and… more
- AbbVie (Irvine, CA)
- …development strategy for the late-stage assets, aligning with the clinical and regulatory development strategy from the Asset Strategy Team (AST). The ... engineering, analytical, and device technical information in conjunction with the project strategy , with full consideration of current regulatory and compliance… more