Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc. Consulting experience, working with a major system integrator or software vendor. Regulatory Affairs, Regulatory Operations or Pharmacovigilance background. Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data and content. PMP certification. Execution experience with Agile methodology and/or ACP Certification. Life More ❯
data issues, as appropriate Oversee and facilitate medical coding activities Collaborate with Clinical Programming on the development and execution of data transfer specifications Collaborate with Clinical Programming and BioMarin Pharmacovigilance (BPV) on SAE reconciliation activities Complete pre-database lock or snapshot checklist activities and related Data Validation meetings with cross-functional stakeholder to approve the DB lock/snapshot go More ❯
choice for 85% of the top 20 Pharmaceutical companies, to define and realize the strategic value of Regulatory Affairs, Clinical Strategy & Operations as well as Quality and Safety (eg. Pharmacovigilance). As a Senior Consultant, you will manage complex and novel consulting projects for Veeva customers in the research and development (R&D) space - managing teams and planning, organizing, and More ❯
choice for 85% of the top 20 Pharmaceutical companies, to define and realize the strategic value of Regulatory Affairs, Clinical Strategy & Operations as well as Quality and Safety (eg. Pharmacovigilance). As a Consultant, you will manage workstreams on consulting projects for Veeva customers in R&D - planning, organizing, and tracking all aspects of delivery. You will analyze problems, build More ❯
proven experience in the pharmaceutical or healthcare industry. Backgrounds in Quality Assurance, Clinical Development, or supervised IT support are all highly relevant. Familiarity with Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and the software development lifecycle for validated systems is required. Veeva Vault experience is strongly preferred. Experience generating quality reports, handling upgrades, or serving as a subject matter More ❯