- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… 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
- Parexel (Des Moines, IA)
- …Experience with delivering effective CAPA management solutions. + Experience with risk management tools and processes within the clinical quality framework. ... and follow up of regulatory inspections. **Primary Duties:** Operational Quality Management : + Develop Risk Assessment and Categorization Tools (RACT) and… more
- CSL Behring (King Of Prussia, PA)
- …Monitor, track and analyze global PV regulations, safety reporting requirements, and risk management guidelines. Maintain and update safety intelligence database ... therapies that make a meaningful difference worldwide. Could you be our next Senior Manager , Regulatory Science? The job is in our King of Prussia, PA office. This… more
- Insmed Incorporated (NJ)
- …& Process is responsible for overseeing the quality monitoring, process management , and continuous improvement efforts that support Insmed's patient services ... to, the following:Oversee the team responsible for quality monitoring, process management and improvement, and end-user training to ensure consistent and compliant… more
- Parexel (Baton Rouge, LA)
- …does not include any direct medical advice on patient care or management + Communicate with relevant sponsor counterparts on challenges and accomplishments related ... actions contributing to the success of the study/project and risk mitigation + Creating a sense of urgency on...Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support - Provide medical input into PV workflows… more
- BeOne Medicines (Emeryville, CA)
- …development intelligence, US Marketing, Global Marketing, US Sales, safety/ pharmacovigilance , molecular diagnostics, new markets, and translational research. The ... Values Essential Functions: + Oversee the daily 1st line manager activities of the Field Medical Team while providing...and report on FMD goals and objectives including performance management and employee development + Prepare, along with HQ… 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
- 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
- AbbVie (Chicago, IL)
- …the following areas: drug development, non-interventional study lifecycle management , risk management , and/or Pharmacovigilance + Demonstrated ability to ... to provide innovative safety-driven strategies, which will maximize product benefit- risk for patients. The Office of the PST plays...of the PST model. As an Epidemiology Study Operations Manager within the Office of the PST, you will… 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
- Nestle (Chicago, IL)
- …Marketing, Technical Operations, Legal, Clinical, Commercial, Medical Affairs, Pharmacovigilance , and Compliance teams. **Key Responsibilities:** * Guide, direct ... agencies (as requested). * Organize cross functional team meetings on management of change controls, labeling supplements and implementation of new/changes to… more
- Sanofi Group (Morristown, NJ)
- …agencies + Demonstrated capability to challenge decision and status quo with a risk - management approach + Ability to work within a matrix organization, within ... Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. + External contacts:… more
Related Job Searches:
Management,
Manager,
Pharmacovigilance,
Pharmacovigilance Manager,
Risk,
Risk Management