Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial & real-world data. Powered by artificial intelligence & delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies & academic researchers accelerate value, minimize risk & optimize outcomes. Medidata serves more than 1,000 customers & partners worldwide & empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com
We know that diverse teams win & are fully committed to selecting leaders & employees that represent the markets in which we operate. We are still led by our Co-founders, Tarek Sherif & Glen de Vries, & have global operations in US, Europe & Asia with over 2000 employees.
The Validation Analyst is focused on software product validation activities along with contributing to the continuous improvement of software development lifecycle (SDLC) & computer system validation processes.
The Validation Analyst will utilize their knowledge of industry best practices on Agile SDLC methodologies & Validation practices, along with knowledge of applicable regulatory expectations, to help drive procedural updates and/or process improvements. The Validation Analyst will be a primary point of contact to Technology teams, & will be responsible for guiding staff to ensure compliance with procedural expectations. The Validation Analyst will be responsible for designing & delivering training to the Technology teams to reinforce SDLC & Validation procedural expectations & related best practices.
The Validation Analyst serves as an SDLC process & validation subject matter expert & is an integral point of contact to the respective product teams within the Technology Department.
Note: The Validation Analyst is not a “hands-on” software testing position.
• Conduct quality reviews of software validation packages
Create and/or update procedural documentation & supporting procedural documentation
• Create and/or update validation documentation (e.g., validation plan, validation report, validation certificate)
• Report on non-compliance issues & assist with preparing CAPA plans
• Evangelize Medidata’s SDLC & CSV process expectations & applicable regulatory expectations (e.g. 21 CFR Part 11, Annex 11)
• Assist with the continuous identification & design of process improvements
• Assist with the identification & implementation of corrective & preventive actions for quality issues
• Assist with the design & delivery of training on SDLC & CSV topics
• Ability to work with a cross-functional team
• Ability to effectively communicate process expectations to the teams
• Ability to evaluate issues & resolve problems or propose resolutions
• Ability to identify risks & take appropriate measures to minimize negative outcomes
• Ability to understand & articulate technical issues
• Proficiency in the use of office productivity tools (e.g. Smartsheets, WebEx, MS Word, etc.)
• Ability to serve as a subject matter expert
Your Education & Experience:
• Bachelor’s degree in Computer Science, Information Systems, or related field or the equivalent work experience in a software development, software testing, or technical writer role
• Minimum of 2 years of relevant SDLC and/or Validation work experience with at least 1 year of experience utilizing an Agile SDLC methodology
• Exposure to the Life Sciences (pharmaceutical, biotech, medical devices) industry & regulatory requirements is a plus
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug & medical device development, enabling life-saving drugs & medical devices to get to market faster. Our products sit at the convergence of the Technology & 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 & intelligent data analytics, bringing an unmatched level of quality & efficiency to clinical trials enabling treatments to reach waiting patients sooner.
Medidata Solutions is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees & 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 & local laws governing non-discrimination in employment in every location in which the company has facilities.