- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible for ... strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director of Specialty Laboratory Quality is responsible for ... and providing regulatory counsel. + Effectively communicates verbally and in writing and able to impact and influence people. + Strong critical thinking to… more
- Bristol Myers Squibb (Princeton, NJ)
- …cell therapies enabling global regulatory approval and launches. The ** Associate Director , Program Management** plays an important role in organizing, ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** Associate Director , Program Management, Global Operations (Inline Asset… more
- Taiho Oncology (Princeton, NJ)
- …and execution, analysis and reporting of data, and authoring/review of scientific and regulatory documents. The Associate Director of Biostatistics will have ... Associate Director , Biostatistics Princeton, NJ, USA...clinical data + Create/author statistical sections of scientific and/or regulatory documents + Manage external biostatisticians to ensure quality… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be ... inspections . + External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary The Associate Director , RBQM - HOCT, ICN will mainly be responsible ... (where relevant, in partnership with CORM) throughout study lifecycle. * Provide regulatory intelligence on current and upcoming regulations to ensure we remain… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , RBQM - HOCT, ICN will mainly be responsible for ... (where relevant, in partnership with CORM) throughout study lifecycle. + Provide regulatory intelligence on current and upcoming regulations to ensure we remain… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director of Specialty Laboratory Vendor Quality will be ... the full range of quality. This role reports directly to the Director , Specialty Laboratory Quality. **Key Responsibilities:** + Support independent quality vendor… more
- Bristol Myers Squibb (Princeton, NJ)
- …Responsibilities: + Develops expertise beyond biostatistics by researching medical literature, regulatory and HTA documents to develop an understanding of the ... clinical, regulatory /HTA and commercial climate. + Contributes to preparation of...data manipulation, graphing & simulation. + Great interpersonal, communication, writing and organizational skills. + Expertise in statistical/clinical trials… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. - CRO / Vendor ... Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health… more