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We are seeking an experienced QA Contractor to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP and FDA regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will collaborate with clinical study teams and internal departments to assess and mitigate risks associated with vendors.
Reporting to the Senior Manager, IT Helpdesk, the Senior Helpdesk Technician is a specialized, hands-on technical role that is the first point of contact responsible for providing help desk support and training support to end users, ensuring quick and efficient problem resolutions in all areas of technology.
The help desk support duties include but are not limited to, resolving computer, mobile device, and peripheral device related problems in supported areas as well as supporting new software platforms, evaluations, and escalations and ad hoc projects as required. The day-to-day workload in...
The AD, Real World Data Analyst plays a pivotal role in our Real-World Data (RWD) and Analytics team. Reporting to the Executive Director this role collaborates closely with stakeholders across the organization to implement our strategic vision for the RWD pipeline and insights generations. The primary responsibilities include ensuring data governance, integrity, and security across the RWD platform, analyzing complex datasets to derive actionable insights, and championing the use of AI and machine learning techniques for enhanced data analysis.
The AD, RWD Analyst supports the development and enhancement of our global RWD data platform, meeting stakeholder needs and adhering to data security standards. Additionally, it evaluates data...
The Regulatory Operations Document Specialist Contractor will focus on formatting documents based on Shionogi standards and support remediation efforts by bookmarking, hyperlinking, and performing quality control measures to ensure our work product is compliant with our electronic submissions. In addition this assignment will focus on providing general assistance to the Regulatory Affairs team as a whole whilst focusing on supporting Regulatory Operations.
The Principal Data Manager oversees and coordinates all Data Management (DM) activities ensuring compliance according to quality standards, regulatory requirements, and project budget from study start-up through study close-out and final reporting.
The key duties and deliverables of this position include collaborating with the Biostatistics, Clinical and Medical Affairs teams in all aspects of supervising the CROs by setting up, managing and completing trial databases and CRFs within timelines with the primary goal of ensuring data integrity.
The Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, and collaboration with regional regulatory authorities. While providing valuable support to higher-level management, the Senior Manager focuses on executing regulatory tasks, ensuring compliance, and facilitating cross-functional collaboration to achieve successful outcomes for our QOL initiatives.
The Clinical Trial Associate (CTA), Clinical Operations will support the clinical project team in the operational execution of clinical trials.
The Senior Director, Regulatory Affairs - GDP provides strategic oversight and direction for regulatory activities on a regional and/or global scale. This role entails leading a multidisciplinary team in developing and executing regulatory strategies to advance our vaccine and bacterial product portfolio through all stages of development and commercialization within specific regions, such as the US. Responsibilities include developing and implementing regulatory strategy, driving regulatory submissions, fostering collaboration with regional regulatory authorities, managing regulatory risks and opportunities, and providing strategic guidance to executive and senior leadership. The Senior Director will serve as a key advisor on regulatory matters, ensuring alignment with company goals,...
