- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all… more
- Boehringer Ingelheim (Ridgefield, CT)
- …area from the regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance , market access and commercial perspective. This role provides ... strategic regulatory guidance to regulatory and cross-functional teams, challenges development programs scientifically, and manages all regulatory aspects through the development and maintenance of new medicinal products and indications. The role is… more
- AbbVie (Florham Park, NJ)
- …role in a TA preferred. + Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. + Must have an in-depth understanding of ... the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements. Must possess excellent oral and written English communication skills. Ability to interact externally and… more
- AbbVie (South San Francisco, CA)
- …for late-stage assets. * Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards ... in conducting research. Contributes to authorship of regulatory responses and may participate in meetings. . Qualifications *Bachelors/Masters with 13+ years of experience, advanced Degree 3+ years of experience *Strong desire to collaborate in a… more
- Taiho Oncology (Princeton, NJ)
- …cross-functional areas (eg, clinical operations, biostatistics, data management, biomarker, pharmacovigilance , quality, etc.) + Knowledge in authoring key clinical ... development documents (eg, study protocol, IB, ICF, CRF, CSR, DSUR, PBRER, and documents for regulatory interactions). + Ability to learn, integrate complex information, and manage competing priorities for program deliverables + Excellent presentation skills… more
- AbbVie (Irvine, CA)
- …with corporate policies. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. The position is based in Irvine, CA. Qualifications + Bachelors degree in the sciences; advanced degree (eg, MS, PhD) preferred. + Ability to provide input and direction to clinical research teams with minimal supervision. +… more
- University of Pennsylvania (Philadelphia, PA)
- …NIH and NCI mandates. + Play a vital role in performing quality reviews of pharmacovigilance data that are evaluated and acted on by the ACC Data and Safety ... Monitoring Committee. + Strictly adhere to all ACC DOCM policies and procedures as well as have a thorough understanding of federal and local policies and guidance for the conduct of clinical research. + Ensure data entered into case report form is accurate,… more
- Sanofi Group (Framingham, MA)
- …knowledge in one or two domains (eg, Operational experience in Clinical, Pharmacovigilance , Manufacturing, Site Quality Head for a Manufacturing Site, etc.). + ... Previous experience as a Regulatory Authority Inspector. + Member of International Society for Pharmaceutical Engineering (ISPE), BioPhorum, BSI, and/or Parenteral Drug Association (PDA) with working group experience. + French speaking and/or other languages… more
- Sanofi Group (Cambridge, MA)
- …teams (business, commercial, medical affairs, clinical affairs, cybersecurity, privacy, pharmacovigilance , legal team and more) to deliver safe and effective ... products that excel in performance and usability. + Monitor and analyze product performance to assess solution effectiveness and drive product adoption in the field. + Stay informed about the latest advancements in patient find and diagnostic technologies,… more