Regulatory Strategy Analyst - AI, Global Compliance and Strategy
Medidata: Conquering Diseases Together
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,400 customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com.
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 highly regulated industries, regulated to ensure the utmost patient, safety, patient data security and patient privacy etc. To ensure Medidata is compliance and to pro-actively drive innovation,
Medidata has a leading- and cutting-edge global compliance and strategy (GCS) department.
GCS has two core functions, excellence in quality management and compliance, and excellence in regulatory strategy. The candidate will support the activities planned within the regulatory strategy arm of the group, but will also become cognizant of the importance of a companywide robust quality management system and the unified protection strategy.
Technology is unquestionably the most rapidly advancing aspect of modern life and the life sciences domain as a whole is one which with quality, intelligence and innovation can yield massive benefits for spectrum of life sciences institutions and patients. This is evident with examples arising in the areas of precision medicine, technology-based biomarkers, the use of synthetic control arms, virtual human modelling and decentralization of clinical trials, and the ability to apply ethical and trustworthy artificial intelligence to healthcare and research scenarios. Science and technology are advancing at ever increasing pace and for confident adoption regulatory frameworks need to adapt to these changes. As a result, over the next decade the sector will see significant regulatory change including at an international, regional and local level. These regulatory changes include
Leadership in tracking, promoting, and advancing the use of Artificial Intelligence (AI) against a developing regulatory landscape.
Collaborate with colleagues on the use of International modernization of the principles of clinical research and the renovation of traditional international good clinical practice guidelines i.e ICH E8 and E6 and the promotion of Diversity in Clinical Trials.
Globally focused approach to adoption of AI in advancing patient care and treatment. Cross-functional teaming to guide product development.
The role essentially is to support the GCS team by assisting with the analysis and research of new AI products in the face of regulations and laws. As key part of the role also includes engaging with authorities and stakeholders in the provision of insight into new technologies and techniques, which are supporting acceleration of clinical development and in turn patients and communities.
The candidate will be responsible for supporting and analyzing the regulatory landscape in the areas of good clinical practice; relevant to Medidata’s business and that of its clients and partners. This could cross a very broad selection of topics such as general conduct and management of clinical trials, precision medicine, virtual trials, big data, artificial intelligence which will be a fundamental facet of the discussions with regulators and new industry guidance and specifically activities (but not exhaustive) include:
Analyzing the GCP regulatory environment and translating into impacts, to Medidata, our clients and patients and making interpretations that are communicable internally and externally.
For new guidelines that are issued by authorities responding to public consultations through coordinating with experts within Medidata but also collaborating
Interface and engage with authorities to support a pro-active communication model that promotes collaborative engagement
Interface and work with trade associations and industry bodies on regulatory and technology initiatives to promote unity and foster industry working collaborations.
Your Education & Experience:
Ability to analyze and organize complex information
Ability to work in internal and external teams
Ability to work independently
Good presentation skills
Excellent written and communication skills
Strategic thinking, thinking outside of the box
Knowledge of good clinical practice and general aspects of data privacy and data protection
The fields of study relevant to the life sciences and healthcare sector
Some practical industry experience focused on regulatory aspects within clinical trials.
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.
Medidata’s solutions have powered over 14,000 clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.