Find jobs in clinical research, clinical trials, CROs, Pharmacovigilance and Medical Information, and Regulatory Affairs. Find a job as a Clinical Research Associate (CRA) or Clinical Research Manager.
Clinical Research jobs in Belgium (4), Bulgaria (1), Croatia (2), Denmark (2), France (1), Germany (4), Greece (2), Italy (2), Multiple Countries (17), Netherlands (1), Poland (3), Spain (2), Switzerland (11) and United Kingdom (8).
You will directly assist the Business Development Director in meeting the strategic, scientific, therapeutic, and commercial needs of MPP. The role contributes to shaping MPP business development strategy through the in...
The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.
Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, maintenance, and termination where applicable, along with all associated deliverables. Contribute to strategy setting in collaboration with line
You’ll be leading a team of Pharmacometricians, from both a technical and scientific perspective, to ensure state of the art pharmacometrics approaches are applied to optimize drug discovery and development. Performing hands-on population PK/PD,
Ensure efficient, compliant and timely management of CPP (Certificate of Pharmaceutical Product) submissions and legalization activities as central coordinating function within GRA; Provide transparent tracking, prioritization and status of workflows
Responsible for supporting the execution of the global medical plan for the assigned product in collaboration with the rest of the global medical team, as well as supporting the necessary cross-functional workstreams, while adhering to the
You will lead and manage the Medical Department ensuring that Clinical Trials are conducted such that subjects' rights, safety and wellbeing are protected and that the Clinical Trial data is reliable. You will assume Medical responsibility for Clinical
Provides leadership and oversight for multiple, complex clinical trials and programs, ensuring delivery of high-quality data and regulatory compliance. Spearheads collaboration with internal study teams and vendors to ensure clinical trial delivery meets
Responsible for providing end to end operational oversight of an oncology clinical trial, including site management, vendor and CRO oversight, monitoring activities, and ensuring trial execution in compliance with protocol, GCP, and regulatory
Planning, preparation, submission and support of regulatory applications in EU for designated projects/products in different therapeutic areas, including new Marketing Authorization applications, line extensions, variations, clinical trial applications,
Serve as the main contact point to support the local pharmacovigilance responsible person (LPVRP) in the assigned region, where applicable; Support the Head of Regional PV in the harmonization of processes across the regions
Leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas. This role involves
Act as a regulatory subject matter expert for ICON. Support initiatives to ensure ICON maintains awareness of new regulatory requirements and opportunities and can deliver services accordingly. Actively contribute to maintaining company awareness of new
Responsible for the development, maintenance and adherence to Genmab’s clinical data standards including eCRFs, edit checks, electronic case report forms (eCRFs) Completion Guidelines, controlled terminology, CDISC, CDASH and etc. The Associate Director