- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related ... RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and… more
- NavaDerm (Bronx, NY)
- …+ Responsible for the clinical lab operations, support and back up Pathology Medical Director in the oversight of all aspects of efficient lab operations + Develops ... of functioning in assigned area + As directed by the Pathology Medical Director , evaluates, and implements new technical procedures for assigned laboratory to ensure… more
- Actalent (Parsippany Troy Hills, NJ)
- Job Description: + Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical ... documents. + Assist and support the review of packaging, labeling , storage, logistics, and distribution documentation of the investigational product.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …working within established timelines of investigational product manufacturing, labeling , release, distribution and return/destruction, and/or helping to establish ... of RFP, assumptions and SOW for CROs and IP services vendors ( labeling , packaging, distribution; IVRS/IWRS) + Provides input, reviews, and approves vendor study… more
- NavaDerm (Bronx, NY)
- …the Pathology Laboratory, while reporting to the Path Lab Supervisor/Lab Director /Practice Manager as needed: PATHOLOGY LAB SPECIFIC DUTIES: + Accepts laboratory ... + Evaluates the acceptability criteria for each specimen and checks for correct labeling , specimen container and source. + Understands the importance of and follows… more
- Merck (Rahway, NJ)
- …contract execution, and ongoing contract management. This role will report to the Associate Director to provide high quality strategic analysis of data to ... and Clinical Supply) for clinical supply chain services (comparators, packaging, labeling , distribution, & onsite FTE's). This includes strategic sourcing of… more