- Gilead Sciences, Inc. (Parsippany, NJ)
- …research through post-marketing + Strong experience in Good Clinical and Good Pharmacovigilance Practices and knowledge of evolving regulations, such as ICH E6 R3 ... + Proven experience advising business functions in the biopharma industry on quality and compliance requirements and continuous improvement + Experience working across a broad spectrum of quality and/or compliance activities, including authoring SOPs, leading… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations, Pharmacovigilance , handling and processing of raw data and external data, ... CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working in fast-paced environment, continuous improvement, project management, change management, and risk management.… more
- ThermoFisher Scientific (Carlsbad, CA)
- …effectively with key internal directorates including Operations, Biometrics, Regulatory, Pharmacovigilance , and Global Product Development to ensure the best ... proposals and plans are developed for clients. + Ensures the proper level of scientific support is delivered in the award and execution process + Promotes innovation and works with Global Medical Officer PPD Biotech to move PPD in a direction to be more… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the assigned therapeutic area from the global regulatory, scientific, pharmaceutical, pharmacovigilance , market access and commercial perspective as well as engage ... in regulatory policy development and foster external stakeholder interactions. The Director, Global Regulatory Strategy Lead will lead and guide the RET. Provide mentorship, direction and support team members, fostering a culture of excellence and continuous… more
- AbbVie (South San Francisco, CA)
- …key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Medical Doctor (MD), Doctor of Osteopathy (DO) or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly… more
- ThermoFisher Scientific (Greenville, NC)
- …functional areas such as clinical operations, data management, biostatistics and pharmacovigilance .** + History with breadth of global responsibility and account ... management. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. **Knowledge, Skills and… more
- Organon & Co. (Des Moines, IA)
- …access teams to achieve goals. + 100% execution under compliance / Pharmacovigilance SOPs (Policies & Procedures) . **Required Education, Experience and Skills** ... + BS degree preferably in sciences or biomedical engineering. + Proven track record in medical device sales. + At least two years' experience in the local healthcare Medical Devices industry. + Start-up / product launch experience. + Experience in women health… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for studies and compound in conjunction with the study medical director and Pharmacovigilance . + May oversee other clinical scientists with respect to assessment of ... these issues. + Informs final decisions regarding study conduct related to scientific integrity. External Interactions + Contributes and leads interactions with key opinion leaders relevant to assigned compounds and therapeutic area. + Contributes to… more
- AbbVie (Mettawa, IL)
- …subject matter experts and advisors from cross-functional teams including pharmacovigilance , legal, regulatory, medical, office of ethics and compliance (OEC) ... and business technology solutions (BTS) to ensure operational excellence and governance of EPE led processes. + Monitor the external environment, to help to drive AbbVie's patient experience capability, proactively reviewing and identifying opportunities to… more
- Insight Global (Wilmington, DE)
- …and drug development areas (Clinical Operations, Data Management, Regulatory Affairs, Pharmacovigilance , Finance, HR, Medical Affairs) null We are a company ... committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive… more