- ThermoFisher Scientific (Cambridge, MA)
- …Maintenance activities. They should provide high quality data outputs for Safety Signal Management , Risk Management and Safety Evidence generation and will ... depend on - now and in the future. Discover Impactful Work: The Associate Manager Safety Data and PV Systems will lead deliverables for GPS (Global Patient Safety)… more
- Amgen (Washington, DC)
- …synthesis; periodic report production + Knowledge of processes and regulations for pharmacovigilance and risk management + Clinical/medical research ... of patients while transforming your career. Global Safety Senior Manager , Rare Disease **What you will do** Let's do...decision-making body. + Assist GSO in the development of risk management strategy and activities: Provide contents… more
- Sumitomo Pharma (Providence, RI)
- …a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to ... to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties and Responsibilities**… more
- BeOne Medicines (Emeryville, CA)
- …Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science ... + Update Reports (PSURs), Periodic Benefit- Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs). + Lead and demonstrate ability to resource,… more
- BeOne Medicines (Emeryville, CA)
- …regulatory communications are audit-ready, documented, and compliant. **Regulatory Intelligence & Risk Management ** + Track global regulatory trends, enforcement ... **General Description** **:** The Manager , Regulatory Compliance Programs reports to the Senior...programs. **Regulatory Document Lifecycle Management ** + Support management of regulatory documentation, including SOPs, risk … more
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position** We are looking for an experienced Associate Director, Program Manager to join our team. This successful candidate will provide program ... management expertise as an individual contributor to teams leading...drugs or devices which improve human health. The program manager may also be assigned to projects that contribute… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …in clinical study team meetings for assigned compounds + Participate in other risk management activities as appropriate for assigned compounds + We may ... The Senior Manager of Global Patient Safety (GPS) will play...PhD, or PharmD + Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech… more
- J&J Family of Companies (Raritan, NJ)
- …Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management , Regulatory Compliance, Regulatory Development, Regulatory Environment, ... submission. Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager , Global Labeling Product Leader. This position is a hybrid role and can… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and advisory meetings; and coordinate grant applications for scientific merit. + Develop risk management documents and ensure that all product failure modes and ... Become a **maker of possible** with us. **Medical Affairs Manager , Infusion Preparation & Delivery (IPD)** **Scope:** In this... risk mitigation measures are included. + Contribute when necessary… more
- Bristol Myers Squibb (San Diego, CA)
- …+ Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management , pharmacovigilance , clinical operations and other departments) for ... We are seeking an experienced **Clinical Medical Writer** with strong project management capabilities to join our growing clinical development team. This hybrid role… more
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