- Lundbeck (Deerfield, IL)
- Director Safety Surveillance US - Remote Opportunity Requisition ID: 5214 Location: Deerfield, Illinois, US Do you want to join a team where the mission is ... in the Deerfield, IL office 1-2 times a month.** **SUMMARY:** The Director , Safety Surveillance US will provide strategic leadership to the Safety Scientists… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Medical Director serves as the Product Safety Physician for complex strategically important developmental programs and creates ... content, reviews core RMP & local + RMPs (or REMS ) and leads execution of RMP elements, documentation of...on the program / portfolio being led. The Medical Director serves as Product Safety Physician for complex strategically… more
- ThermoFisher Scientific (Wilmington, NC)
- …well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS , RMP and CSR). **Essential Functions:** Manages all medical aspects of ... review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS , CTD modules, etc. to ensure that the medical content is accurate and… more
- Lundbeck (Deerfield, IL)
- Medical Director GPS US - Remote Opportunity Requisition ID: 5173 Location: Deerfield, Illinois, US Do you want to join a team where the mission is meaningful, the ... + Contributes with medical-scientific input to Risk Management Plans, RiskMAPS and REMS , as relevant + Supports the implementation of a measurement of effectiveness… more
- ThermoFisher Scientific (Wilmington, NC)
- …well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS , RMP and CSR) **Essential Functions:** Manages all medical aspects of ... review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS , CTD modules, etc. to ensure that the medical content is accurate and… more
- Kelly Services (Morrisville, NC)
- **Kelly(R) Science & Clinical** is seeking a Neurology Medical Director for a fulltime, contract position with a large CRO client. If you're passionate about ... well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS , RMP and CSR). **Essential Functions:** + Manages all medical aspects of… more
- Omnicell, Inc. (Santa Clara, CA)
- **Regional Director of Pharmacy Operations (FQHC & Ryan White Pharmacies) (Remote)** **SUMMARY** Responsible and accountable for all operations within a defined ... as state and local laws and regulations. + Detailed understanding of REMS programs relevant to specialty pharmaceutical products. + Has sufficient knowledge,… more
- J&J Family of Companies (Raritan, NJ)
- Director , Medical Safety Officer: Immunology - 2406178041W **Description** Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Immunology to ... (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy ( REMS ), as well as other activities related to managing the safety profile… more
- Omnicell, Inc. (Grapevine, TX)
- **Regional Director of Pharmacy Operations** **SUMMARY** Responsible and accountable for all operational issues within a defined geographical region, shall be ... as state and local laws and regulations. + Detailed understanding of REMS programs relevant to specialty pharmaceutical products. + Has sufficient knowledge,… more
- Teva Pharmaceuticals (North Wales, PA)
- Director , Commercial Trade Operations - North Wales, PA Date: Apr 12, 2024 Location: North Wales, United States, Pennsylvania, 19454 Company: Teva Pharmaceuticals ... **The opportunity** As a part of the world class Customer Operations Department, Director of Commercial Trade Operations is responsible for the leadership of the… more
- BeiGene (San Mateo, CA)
- …stage (phase II-III) safety science activities. The position has no direct reports. The Director Safety Scientist is part of a team that performs high quality and ... to the authoring and maintenance of core RMPs and local Risk Management Plans/ REMS . + Assist in leading and improving the oversight and monitoring of effectiveness… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Director , PV Risk Management in Cambridge, MA with the following requirements: ... (NDA submissions); Advise product team on the maintenance and implementation of REMS program for assigned product and support FDA response requests; Support health… more
- Omnicell, Inc. (Salisbury, MD)
- …as state and local laws and regulations. + Detailed understanding of REMS programs relevant to specialty pharmaceutical products. + Has sufficient knowledge, ... training, and expertise in pharmacotherapeutics to oversee the pharmacy patient management program. + Possesses leadership skills and abilities: + Time management and organizational skills; + Professionalism; + Communication skills, both oral and written; +… more
- Gilead Sciences, Inc. (Chicago, IL)
- …appropriate use of our product. This opportunity will report to the Senior Marketplace Director for a specific region. The key stakeholders for this role are those ... Management Guide, Product Insert [PI]). + Helps Key Account Director educate customers at treatment center on CAR T...+ Manages ongoing compliance-related activities at the ATC (eg, REMS Program, periodic audits) once the ATC is operational… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …working closely with Drug Safety Global Safety Team (GST) Chair (Medical Director ). The Manager, Drug Safety will perform signal management process activities for ... queries), Safety Surveillance Plans,and CCDS]. + Supports the writing of regional REMS /RMPs for assigned MTPG global products as needed. + Provides support for… more