- 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
- 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
- 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
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance ) Strategy/Portfolio Management, Global Device ... Job Title Senior Director, Clinical Development & 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
- Randstad US (Trenton, NJ)
- …Knowledge of Good Pharmacovigilance Practices (GVP) is required - Knowledge of Regulatory Affairs and/or Labelling regulations are required - Can base level ... Sigma certification, or equivalent certification, preferred but not required skills: Pharmacovigilance , CAPA, Regulatory Affairs Strategy Equal Opportunity… 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …The MDMP interacts and partners with marketed products R&D function leads ( regulatory affairs , pharmacovigilance , global development operations and project ... Establish integrated partnership(s) with R&D functional leads on assigned R&D MPT ( regulatory affairs , pharmacovigilance , global development operations). +… more
- BeiGene (San Mateo, CA)
- …including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance + Appropriate experience with ... **General Description:** The Senior Medical Director serves as the Product Safety...and approved BeiGene products + Leads Development and Medical Affairs product teams in the identification of, and handling… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Compliance functions in Data Science Institute (DSI), Global Development Operations (GDO) and Global Regulatory Affairs (GRA). + Reports to the Head of CPMQ and ... Zurich, Switzerland **About the role:** + Leads the global Clinical, Pharmacovigilance , and Medical Quality Compliance organization, providing quality oversight of… more
- Boehringer Ingelheim (Ridgefield, CT)
- …assigned assets, lead the Regulatory Excellence Team (RET) and represent Global Regulatory Affairs (GRA) on the Evidence Team. The Director, Global ... molecule) + Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs , RAC certification Technical expertise: + In-depth… more
- AbbVie (South San Francisco, CA)
- …The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to ... as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of physicians in the global Inflammation Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. ... investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Periodic Benefit… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …product development, registration, and post-market support + Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety. + ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development functions. MTPA is dedicated to improving the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …team of physicians in the global CREA Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. This ... investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Periodic Benefit… more
- Sanofi Group (Cambridge, MA)
- …programs management. + Significant experience in Medical Governance, Medical Quality, Pharmacovigilance , Regulatory Affairs , Medical Operations (at global ... to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty Care MAP… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Senior Corporate Counsel for Pricing and Access will primarily serve as counsel for specialty pharmacy contracting and other healthcare ... programs and internal policies and procedures to satisfy evolving industry and regulatory compliance requirements within the specialty pharmacy space in the US. This… more
- AbbVie (North Chicago, IL)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. ... of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. + May oversee… more
- Sanofi Group (Bridgewater, NJ)
- …incumbent will work closely with the Sanofi Vaccines Research and Development, Public Affairs , Regulatory Affairs , Commercial, Value and Access and Franchise ... medical expertise of functional areas such as marketing, clinical development, pharmacovigilance and regulatory in compliance with law, ethical/scientific… more
