Senior Lead, Global Compliance and Strategy
il y a 1 mois
Medidata: Powering Smarter Treatments and Healthier People
About the Team:
Medidata is the leader in developing the technologies that allow our customers to get the medicines to patients faster. Building on our long history of delivering world-class clinical applications to the life sciences industry. The Life Sciences industry is globally one of the most regulated industries, regulated to ensure the utmost patient, safety, patient data security and patient privacy to ensure Medidata is compliance and to inspire creativity. Medidata has a leading- and cutting-edge global compliance and strategy (GCS) department. With Medidata's continued growth in the Asia regions (including Japan, China, Korea, Singapore, and Australia), you will be a geographically local resource focusing on Medidata's Quality Management System and regulatory strategy. Enable both internal and external stakeholders to progressively enhance Medidata's value proposition through the adoption of emerging clinical trial technologies while meeting and navigating global regulatory expectations.
Responsibilities:
Reporting directly to the Director, Global Compliance and Strategy ("GCS") APAC, you will:
- Engage with important local regulatory agencies in the APAC region ( MFDS (Korea), HSA (Singapore), TGA (Australia)) and government authorities if applicable to ensure that Medidata's interest as a Software as a Service (SaaS) technology company serving regulated companies is considered in regulatory guidance documents and agency perceptions.
- Interact directly with customers to address quality and regulatory related matters relevant to the use of technology in performing clinical trials.
- Collaborate cross-functionally with Medidata departments ( Legal, Information Technology, Product Development) to contribute to achieve Medidata's goals, business plan, and long-term strategy.
- Grow Medidata's Unified Protection Strategy in collaboration with Information Security, Data Privacy and Cloud Operations and work with the Quality/Customer Management and Regulatory functions within GCS.
- Collaborate with GCS peers in the performance and delivery of daily activities of the GCS organization.
- Balance multi priorities, workload, and complete assignments to ensure the team achieves overall customer-focused mission and objectives.
- Fulfill the responsibilities for providing operational support to GCS-managed programs ( quality incident management, internal quality system audits, customer audit/inspection needs).
Qualifications:
- Understanding of regulations governing clinical trials, including:
- Framework guidelines including ICH Good Clinical Practices (GCP) and regional distinctions.
- Clinical Regulations ( KGCP, specific requirements in South Korea on Clinical trials, MFDS inspections).
- Regulations on data management in clinical trials
- Computer Systems Validation
- Experience in clinical trial processes and technologies, including a working knowledge of trial master file and site master files (TMF/SMF) and eTMF.
- Understand quality systems processes and enablement including auditing, root cause analysis and CAPA development.
- MFDS inspection experience is preferred.
- Experience working with ownership to evaluate requirements and propose solutions.
- Teamwork spirit and experience establishing communications and engagement with prospects
- Fluent (read, write, speak) in English and Korean.
- Reside in Seoul, travel within the region.
- Bachelor's degree required with 8 years of experience, 5 years of experience with a Master's; or equivalent years of experience in the life sciences industry and/or medical/clinical operations.
- Requires beyond 2 to 3 years of experience in clinical development quality assurance.
- Understanding of regulations governing clinical trials including Clinical Regulations and Framework guidelines including ICH Good Clinical Practices (GCP).
- Demonstrated experience as a compliance functional expert (especially with regards to clinical processes and technologies) with ability to present to corporate executives.
- Inspection management experience.
- Travel expected at approximately 10%.
- Work with ownership
- Prior experience with a large central IRB or Ethics Committee is preferred.
Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, life and disability insurance; paid time off; paid sick leave; Employee Assistance Program; and paid parental leaves.
Applications will be accepted on an ongoing basis until the position is filled.
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