- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- …Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's Research Labs ... facility (inclusive of RY119) supports the formulation and filling of clinical , stability, and developmental Sterile, OSD and Inhalation supplies. These facilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… more
- Merck & Co. (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of ... pipeline.This person will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Rahway, NJ)
- …and project management responsibility. The Specialist -Engineering position will report to the Associate Director , Engineering and will be a member of the EF ... interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new technologies. -… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... management of Senior Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/ Associate... committees Participate as a member of the first safety committee chaired by non- clinical , where … more
- Merck & Co. (Rahway, NJ)
- …understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director , MACS Operations and will be a member of the ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for operational improvements and seek agreement through consensus management.RelationshipsReports to an Associate Director / Director within the NNI ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … safety information for all Novo Nordisk products. Relationships Reports to Associate Director , Patient Safety Training. Internal relationships include ... Safety database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure… more
- System One (Basking Ridge, NJ)
- Associate Director , Clinical Safety MD Pharma In New Jersey - Remote (no west coast, only EST or CST) 12 month contract | Up to $100/hr dependent on ... a plus + international MD is okay + 1-3 years of Pharmacovigilance (PV)/ clinical safety experience in pharmaceutical drugs either from relevant work experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Associate Director to join our Clinical Development team. The Associate Director Clinical Sciences leads in the development, evaluation, planning ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Promotes consistent first line… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …therapeutic area preferred, along with relevant industry experience. A minium of 2-3yr ( Associate Director ), 4-8yr ( Director ) prior industry experience or ... The Associate Medical Director works with their...ICH and GCP guidelines as well as SOPs regarding safety * Authors clinical sections of communications/documentation… more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , Clinical Data Standards is a leadership role ... This role reports to Director or Executive Director , Head Standards Management & Steward within Clinical & Safety Data Insights and Analytics. **Position… more
- AbbVie (Branchburg, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Clinical Development will have global or ... Program Lead and Clinical Science Lead and Clinical Scientist. The Associate Director ,...or risks (eg, changes or significant risks to the Clinical Development Plan, new safety concerns) upon… more
