- Bristol Myers Squibb (Madison, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director Commercial Regulatory Affairs ** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply...+ Proven aptitude to analyze and interpret efficacy and safety data + Experience communicating and negotiating with OPDP/APLB… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …please visit Gilead.com. We have an exciting opportunity within the US Medical Affairs (USMA) organization for an Associate Director within Oncology Medical ... experience inOncologyMedicalAffairs + Industry experience with knowledge of all applicable regulatory and legal requirements for Medical Affairs activities +… more
- AbbVie (Florham Park, NJ)
- …of work may include clinical trials, patient safety , and global medical affairs . The Associate Director works in partnership with experts in multiple ... and drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety , or GMA) to create development strategies for… more
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Established Brands Associate Director, Medical Affairs , is responsible for leading ... + Work closely with key cross-functional matrix partners: Commercial, Marketing, Regulatory , Medical Information, Safety , Labeling, Supply & Manufacturing,… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …study team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + ... products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of...sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex… more
- Ascendis Pharma (Princeton, NJ)
- … Safety Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA safety ... for employees to grow and develop their skills. The Associate Director, ICSR Management Team reports to the Director,... regulatory guidance documents; working knowledge of global safety regulations. + Ability to travel up to 20%… more
- AbbVie (Florham Park, NJ)
- …of work may include clinical trials, patient safety , and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple ... and drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety , and GMA, etc.) to create development… more
- Merck (Rahway, NJ)
- …safety monitoring, analysis of data and communication of study findings; (b) **Global Regulatory Affairs and Clinical Safety :** Focus on late-stage and ... working with clinical and cross-functional teams as clinical programs progress toward regulatory approvals. Successful candidates will spend their first year in one… more
- embecta (Parsippany, NJ)
- …within the organization. Creates/manages product Plans/PSURs in collaboration with Medical/ Regulatory Affairs , R&D, Customer Service, and others. Leads ... functional departments, to assess anddetermine suitability of product, impacts to regulatory compliance, and patient safety forproducts outside of embecta's… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …requires strong collaboration with cross-functional teams, including Platform Product R&D, Regulatory Affairs , and Manufacturing, to deliver safe, effective, and ... of the Materials Science team in Franklin Lakes NJ, reporting to the Associate Director, Materials Science. Our R&D Engineers and Scientists are responsible for… more
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