- AbbVie (North Chicago, IL)
- …key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications 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… more
- ThermoFisher Scientific (San Diego, 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
- AbbVie (Irvine, CA)
- …for key regulatory discussions. *Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications *Bachelors degree in the sciences; advanced degree (eg, MS, PhD, OD, MD, PharmD) preferred. *At least 8 years of product development experience with 5 years of experience in consumer eye care in the… more
- Astellas Pharma (Northbrook, IL)
- …collaboration:** + Collaborate within Development: -Development -Regulatory Affairs - Pharmacovigilance + **Collaborate with divisions outside of Development:** ... -Market Access -Commercial -Human Resources -Legal + Ethics & Compliance **Qualifications Required:** + _Educational Background:_ -US: Doctorate Degree in Health-Related Sciences: ie: MD, PhD, PharmD, DNP, DO + _Years of Experience:_ Minimum 5 years… more
- Takeda Pharmaceuticals (Boston, MA)
- …project management, clinical monitoring, data management process, regulatory affairs, pharmacovigilance , etc.) to enable meaningful dialogue within Takeda and with ... partners. + Proven experience in Alliance/Partnership excellence: deep understanding/experience of building, maintaining, and closing partnerships including tools/methods. + Expertise in the ability to perform root cause analysis, develop corrective actions,… more
- Takeda Pharmaceuticals (Boston, MA)
- …compounds. + Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. + Oversees ... and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. + Responsible for evaluation of external interactions in the context of overall development… more
- BeOne Medicines (San Mateo, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Essential Functions of the Job:** + Facilitate generation of, author, update, and/or review key documents, including, but not limited to: + Protocol concepts, synopses, protocols, and amendments o Informed consent documents; + Investigator Brochures o… more
- AbbVie (Irvine, CA)
- …health authority meetings. + Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Bachelors degree in the sciences; advanced degree (eg, MS, PhD, PharmD) preferred. + Ability to provide input and direction to clinical research with appropriate supervision. + At least 5 years of clinical… more
- BeOne Medicines (San Mateo, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Key roles and Responsibilities:** + Key contributor in Clinical development strategy, planning and leading presentations to various internal governance committees + Provides leadership and clinical oversight across all assigned studies and programs (up to 2… more
- University of Maryland, Baltimore (Baltimore, MD)
- …science, including: Chemistry, Manufacturing, and Controls (CMC); Clinical Research; Pharmacovigilance ; Phase IV Research (eg, Pharmacoepidemiology); and Drug and ... Biologics Discovery. Additionally, responsibilities include a Certificate in regulatory science, which is the first two courses in the MS in Regulatory Science. The student population for the program possess a diverse range of backgrounds including regulatory… more