- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …decision-making and cross-functional collaboration + Oversee end-to-end program management processes, including planning, tracking, and reporting across key ... + Implement and optimize systems and tools to enhance productivity and data management within GMA + Develop and track key performance indicators (KPIs) to measure… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …teams as the data science expert supporting pre-launch planning. Exceptional project management , communication skills and ability to deliver high quality insights in ... launch. This role is dynamic, fast paced and requires superior project management skills. **Key responsibilities:** + Manage data acquisition and analytics to… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …manner to meet required timelines. + Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and ... aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS);… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …teams: Strategic Planning, Business Solutions & Analytics, Vendor & Contracts Management , Governance & Procedures, and Global Medical Evidence Operations ensuring ... of strategic and tactical planning and execution. **Operational Excellence and Team Management ** + Lead and manage core operational pillars within Medical Affairs… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …listings for FDA meeting briefing packages. + Support statistical needs for market access and publications. + Core team of developing final study report (FSR), ... across different functional areas such as clinical, regulatory affairs, asset management , safety and clinical operation. + Familiar with regulatory submission… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …degree (Master's/Ph.D.) in quantitative field highly desired (Statistics, Management Science, Operations Research, Engineering, Accounting, Business, Marketing, ... understanding of various syndicated pharmaceutical datasets from IQVIA, Symphony, Market Access Data (ie patient longitudinal data, claims data, distribution, sales,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …preferred + 7+ years of experience in Medical Affairs, Field Medical, Market Access , or related functions within the pharmaceutical or biotech industry **Skills and ... payer and policy environments + Excellent communication, leadership, and project management skills + Strong understanding of pharmaceutical compliance and regulatory… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …role collaborates with **Business Analysis team** to ensure field teams have access to **actionable insights and a consistent reporting framework** that drives ... execution and provide feedback to optimize performance at all levels + **Compliance Management :** + Must comply with all state and federal laws, regulations and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …including but not limited to Translational Research & Biomarkers, Clinical Management , Global Regulatory Affairs, Global Clinical Development (late phase), Data & ... expense priorities pertaining to the CNS portfolio. **Compliance, Quality, and Risk Management ** + Ensure adherence to GCP, ICH, and applicable regulations; drive… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …(Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies Chart (Level X) ... in regulatory affairs or related areas (eg, clinical development, project management , quality assurance, etc.) in pharmaceutical or healthcare related industry.… more