- Eisai, Inc (Nutley, NJ)
- …Negotiation, Industry/ Regulatory Knowledge , Legal & Reputational Risk Management , Legal Knowledge , Mentoring/ People Development, Stakeholder ... pharmaceutical regulatory counseling. Essential Functions: Provides proactive and day-to-day legal support, advice and counsel on a variety of...Member in good standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse laws… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders ... for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports...of standard processes and contract templates in cooperation with Legal Department and PV functions. Assist in the development… more
- Merck & Co. (North Wales, PA)
- … management ; the ability to balance a large project load General knowledge of database management . Ability to work independently with minimal ... not limited to:Regulatory pathways and options, documentation; risk-benefit analysis techniquesWorking knowledge of eTMF and Clinical Trial Management systems21… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and negotiate contracts.Lead cross-functional teams and collaborate with Quality, Legal , CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to prepare ... product competitiveness.Support CMO contract negotiations in conjunction with alliance management .Ensure target inventory levels are maintained and reported monthly.Build… more
- Eisai, Inc (Nutley, NJ)
- …with critical internal business partners (brand management , sales management , finance, pricing, federal government affairs, legal , compliance etc.)Customer ... Markets, Market Access and Coverage Services, Sales, Marketing, Government Affairs, Legal , Compliance, Medical, and Training.The incumbent is expected to be able… more
- Eisai, Inc (Nutley, NJ)
- …project teams involving Marketing, Sales, Managed Markets/Market Access, Legal , Regulatory, Medical, PR, agencies, actively soliciting team expertise ... recent launch experience, digital marketing, life cycle planning, finance/forecasting/budget management , sales force training, IC plan development, KPI tracking,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across departments, and maintaining a proactive approach to regulatory risk management and industry engagement. The individual will serve as the primary ... regulatory advisor for cross-functional teams, including marketing, medical affairs, and legal , on the product material review team (PMRT), and will act as the main… more
- Formation Bio (New York, NY)
- …contracts, including CROs, CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clinical, regulatory, pharmaceutical sciences/technical operations in the biopharmaceutical industry.Excellent knowledge of project management discipline and its ... OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Support medical readiness activities for market launches and life cycle management for select indications/projects. Gains strategic and planning alignment across ... the Senior Director, such as scientific symposium and medical congresses, within legal and compliance regulations.- Collaborates across functions to support GMA MIE… more
