- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of ... 10 or More Years pharmaceutical industry experience required- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and… more
- Merck & Co. (North Wales, PA)
- …Experience/Skills We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs , Quality Assurance, Clinical Affairs , Pharmacovigilance , Biology, ... arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement...& networking opportunities within and beyond RDH Exposure to Senior level positions within the metrics process Hands-on experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with external vendors and to contribute to study logistical conductance; with Regulatory Affairs to align study with health authority requirements; with ... design, and conductance of early development clinical studies; the preparation of regulatory documents to file IND and report studies; and the representation of… more
- Astellas Pharma (Northbrook, IL)
- …clinical operations, Data Sciences, Pharmacovigilance , Clinical Pharmacology, Bioanalysis, Medical Affairs , IT, IGD, Regulatory Affairs . + Frequent ... and procedures comply with national and international requirements for the pharmacovigilance function and the collection and reporting of safety information. This… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in Lexington, MA with the following requirements: Bachelor's degree in Clinical, Regulatory Affairs , Pharmacy, or related field or foreign academic equivalent ... best of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Senior Manager, Pharmacovigilance (PV) Business Partner Relations… more
- University of Pennsylvania (Philadelphia, PA)
- …Monitoring Specialist Senior Job Description Summary The CRP Safety and Pharmacovigilance Manager plays a pivotal role in the Clinical Operations function by ... and much more. Posted Job Title CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy) Job Profile Title...all CCI clinical trials. The Manager monitors adherence to regulatory requirements (ICH, FDA, NIH, NCI, etc.) and GCP… more
- ThermoFisher Scientific (High Point, NC)
- …Assessment of RA changes and change controls + Represent Regulatory Affairs in project teams + Pharmacovigilance support + Biostudies **Additional ... the FDA. Additionally, this position requires representation and advisory support to the Regulatory Affairs (RA) team in R&D project teams, providing expertise… more
- Boehringer Ingelheim (Ridgefield, CT)
- …on developments in the assigned therapeutic area from the global regulatory , legislative, scientific, medical, pharmaceutical, pharmacovigilance , market access ... For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance ) Strategy/Portfolio Management, Commercial and ... Job Title Senior Director, Clinical Development and Medical Affairs...aspects of registration activities with a working knowledge of regulatory affairs , in the development of the… more
- AbbVie (Mettawa, IL)
- …strategic and operational leadership into global oncology pipeline related medical affairs activities including but not limited to; medical and scientific strategies ... within the pipeline and strategic governance frameworks. + Initiates medical affairs activities, generation and dissemination of data supporting the overall pipeline… more
- J&J Family of Companies (Raritan, NJ)
- Senior Director, Head of Global Medical Affairs for Cardiovascular & Metabolism - 2406177222W **Description** Janssen Global Services, LLC is part of the Janssen ... Pharmaceutical Companies is recruiting for a ** Senior Director, Head of Global Medical Affairs ...regulatory requirements + Good understanding of basic research, pharmacovigilance processes and reporting requirements + Ability to build… more
- AbbVie (Mettawa, IL)
- …promotional and non-promotional materials. Contributes to the creation of medical affairs externally facing and training materials in accordance with established ... polices and standards, including regulatory guidelines to meet customer needs. Functions in a...and ensures communications are supported by medical communication standards, pharmacovigilance standards, SOP's and all other quality and compliance… more
- AbbVie (Mettawa, IL)
- …clinical development process for Phase 1-IV or extensive knowledge of medical affairs including compliance and regulatory requirements. Key Characteristics of ... and tools to monitor, measure, and analyze performance/impact of Medical Affairs team strategy and execution across stakeholders within a specified indication.… more
- Boehringer Ingelheim (Ridgefield, CT)
- …+ Chair the Asset Benefit Risk Team consisting of experts in Pharmacovigilance , Medical Affairs , Epidemiology and Biostatistics and other disciplines as ... appropriate + Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk management activities to BI… more
- Randstad US (Guilderland, NY)
- …within business partners, such as Business Alliance/Development, Clinical Development, Regulatory Affairs , Clinical Operations, Quality Assurance, Legal, and ... senior manager/associate director, programs and digital assets. +...and maintaining PVA's ensuring compliance to internal processes and regulatory compliance. + Be responsible for ensuring that the… more
- Kelly Services (Seattle, WA)
- …hiring a Sr. Medical Information Specialist with clinical trial and pharmacovigilance experience for a leading Biotechnology client actively making strides on ... + **Customer-focused group, Sr. Medical Information Specialist works within Medical Affairs and is responsible for responding to unsolicited inquiries regarding the… more
- BeiGene (San Mateo, CA)
- …including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance + Appropriate experience with ... a meaningful and lasting impact on cancer patients **General Description:** The Senior Medical Director serves as the Product Safety Physician for complex… more
- Merck (North Wales, PA)
- …We are Looking for:** . Minimum: Bachelor's Degree in Regulatory Affairs , Quality Assurance, Clinical Affairs , Pharmacovigilance , Biology, Engineering, ... arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement...networking opportunities within and beyond RDH . Exposure to Senior level positions within the metrics process . Hands-on… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Division Medicine. You will focus on Medical Affairs , Patient Safety and Pharmacovigilance (PSPV), Regulatory Affairs , and Epidemiology. In more detail, ... years of experience in auditing and/or experience in a senior advisory role in quality management and/or long term...the pharmaceutical industry in a relevant medicine function (Medical Affairs , Pharmacovigilance , Regulatory Affairs… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of cross-functional evidence team (Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory , Medical Affairs , Market Access, ... thought leaders, industry bodies, etc. + Track record of interaction with regulatory Affairs authority, international societies and other relevant stakeholders.… more