- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Rahway, NJ)
- …Within QP2, you have a uniq ue oppor t unity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting ... Standard business hours You've worked hard to become the professional you are today and are now ready to...leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance … more
- Merck & Co. (San Francisco, CA)
- …proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...Proficiency in R, NONMEM or other similar programing language. Professional working proficiency in written and verbal communication. #EligibleforERP#QP2Current… more
- Genmab (NJ)
- …providing SDTM mapping guidanceEnsures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study ... the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange… more
- Merck & Co. (Durham, NC)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director,… 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
- Merck & Co. (Millsboro, DE)
- …biosafety programs and policies to ensure a safe working environment in compliance with local, state, and federal regulations. The Sr. Specalist of Biosafety ... Associate Director of Safety & Environment at Millsboro, DE.Responsibilities:Ensure compliance with internal and external biosafety regulations and guidelines… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Marketing, CX and Marketing Enablement, Market Access, Legal, Compliance , Insights/Analytics, Communications, Finance, and Market Research. External relationships ... and optimizations across both live and self-service support Maintain robust compliance , quality and privacy standards in handling customer information and programs… more
- Merck & Co. (Rahway, NJ)
- …cross-functional experts as necessary to facilitate progress.Actively participate in regulatory audits and inspections in close collaboration with business ... and the Quality unit, providing necessary documentation and addressing any regulatory inquiries. Skill sets: Highly collaborative problem solver with 5+ years… more
