- Takeda Pharmaceuticals (Boston, MA)
- …overall safety information for studies and compound in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. + Makes final decisions regarding study conduct related to scientific integrity. + **External Interactions** + Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to… more
- Takeda Pharmaceuticals (Boston, MA)
- …overall safety information for studies and compounds in conjunction with Pharmacovigilance . + **External Interactions** + Directs activities involved in interactions ... with regulatory authorites/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these… more
- ThermoFisher Scientific (Wilmington, NC)
- …practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs, Clinical, Quality, Pharmacovigilance and Legal teams to ensure alignment and awareness with ... key areas of interest and hot topics. + **Communication:** Contribute to the creation of and distribute internal newsletters, alerts, and briefing documents tailored to various audiences. Publish relevant selected content to internal Engage forum. +… more
- Sumitomo Pharma (Trenton, NJ)
- …for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of ... clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders. + Author manuscripts and… more
- Sanofi Group (Cambridge, MA)
- …needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Identifies data collection opportunities ... during stakeholder interactions and reports these using approved processes. + Maintains awareness of clinical trial activity within territory and suggests clinical trials sites as requested. + Responds to unsolicited requests regarding interest in investigator… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …EMA, PMDA, ICH, etc. + General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products. + Confirm list of upcoming ... regulatory meetings/workshops/conferences remains current. **Qualifications** + Master's degree in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …organization including, but not limited to, clinical compliance and pharmacovigilance , electronic systems and laboratory compliance, and quality documents and ... training administration. + Provide oversight to Medical Affairs quality and governance and collaborate with Gilead's Chief Compliance Officer on healthcare compliance execution. + Promote a culture of GxP quality across R&D with the highest levels of integrity… more
- Boehringer Ingelheim (Ridgefield, CT)
- …feedback from regions/countries. + Provides product specific input to global Pharmacovigilance (PV) and global Regulatory Affairs (RA). + Develops and/or provides ... input to, and has responsibility for the execution of global Publication strategies and tactical plans. Where relevant, writes and, in collaboration with the (A)HoM reviews and approves publications within his/her project(s). + Chairs or acts as member of… more
- Sanofi Group (Cambridge, MA)
- …Project Heads, Clinical Research Director, Safety Officer and Pharmacovigilance , Translational Medicine, Regulatory Affairs, Biostatistics, Clinical Study Units, ... Medical Affairs, and CROs to optimize study design and execution. **Study Document Development** + Author, review, and validate study-related documents including trial protocols, informed consent forms, case report forms, risk management plans, training… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …data collection. * Collaborates closely with Clinical Research Operations, Medical, Pharmacovigilance , and Biostatistics to ensure seamless data flow and data review ... leading to clean datasets for analysis. * Ensures storage of all DM documents in the trial master file to support inspection. * Mentors junior staff and contributes to departmental growth and development. **Qualifications** * Bachelor's degree in life… more