职位描述
The Clinical Inspection Readiness Leader (CIRL) is an “expert” leader responsible to lead Clinical Inspection Readiness (IR) and Pre-Approval Inspection (PAI) activities and to identify strategic solutions for continued improvement across clinical, where needed.
The CIRL is expected to consistently lead in the process for gathering, analyzing and sharing of best practices and lessons learned. The CIRL may also participate in the design, implementation and maintenance of the Quality Risk Management processes and system within the Clinical perimeter, ensuring alignment with the evolution of the regulations and business needs. He/She can also be a Clinical Quality Risk/Alert Leader for assigned risks.
Overall, the CIRL leads large transversal projects that support inspection readiness for which significant changes/improvements to business processes are expected across R&D and beyond. He/she leads via a project management approach, through optimized processes, new technologies and innovation.
职位要求：
Experience required: Minimum of at least 12 years’ experience in the pharmaceutical industry, with at least 8-10 years’ experience in GCP clinical and/or GCP quality operations-related roles (e.g., GCP auditing, clinical trial monitoring, trial management or Pharmacovigilance) AND demonstrated ability to lead complex projects/assignments.
An extensive knowledge of Research & Development with past experience in clinical operations, preferably global clinical trial management and/or GCP quality assessment/assurance.
The following skills are also of particular importance:
Experience with CFDI, FDA, EMA or other regulatory inspections of sponsor, investigator sites, or CROs Quality focused with a high degree of personal accountability and commitment Demonstrated skills in self-motivation, taking initiative and working independently.
Strong project management skills (global clinical projects
clinical process improvement projects) including:
-Results driven with attention to detail and quality while overseeing and connecting with contributing stakeholders
-Excellent team leadership, presentation, interpersonal and communication skills (written and verbal)
-Rigor, diplomacy and good analytical abilities
-Strong facilitation skills: ability to lead effective cross-location and cross-functional meetings, through discussions on complex and potentially controversial topics.
-Demonstrated ability to bring consensus among diverse cross functional teams and to drive results within established timeline
-Demonstrated ability to anticipate problems/ changes impacts, consequences, and delays
work proactively and take the initiative for corrective measures.
-Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise with ability to prioritize assignments in accordance with assigned project deadlines.
Strong knowledge of international good clinical practices (ICH) and understanding of current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of clinical trials, understanding of FDA Compliance Manual & EMA Compliance Manual.
Knowledge about requirements of New Drug Application (NDA)/ Market Authorization Application (MAA) submissions and e-submissions Strategy focused with ability to extrapolate detail without losing sight of big picture.
Ability to analyze trends and determine strategic improvement needs
ability to execute and monitor the implementation and progress of such improvement processes.
Competent in English (both written and verbal) to interact effectively in an international environment.
