Business Documentation Process Specialist

Client Services Iselin, New Jersey

Position at Medidata Solutions

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

Your Mission:

 The Business Documentation Process Specialist is responsible for analyzing and documenting business processes and their interactions within and across departments, in relation to the implementation of Medidata Clinical Cloud (MCC) software and client enablement.

This person will apply their skills in business analysis as well as project management, while exhibiting leadership in process re-engineering and process implementation.

  • Analyze business tasks and workflows to determine potential system/tool and process improvements

  • Develop process flows leveraging tools such as Blueworks 

  • Design and develop new or updated process solutions and associated procedural documentation such Standard Operating Procedures (SOPs), Work Instructions, and Best Practices and their associated templates/forms, together with Subject Matter Experts (SMEs) leveraging standard quality formats

  • Independently lead teams of SMEs to implement changes to Company’s business systems and processes, interacting and working collaboratively with teams across Medidata globally including Professional Services, Quality, and Product  Development teams

  • Optimize existing processes to ensure the most efficient and effective methods are employed when working with Company’s internal systems 

  • Consult with staff globally to understand their process improvement requirements

  • Collaborate with other Medidata representatives, such as Product Adoption and Optimization (PAO), to analyze and extract pertinent information about current business processes with the goal of documenting and optimizing those processes and implementing best practices

  • Assist with process enhancements, particularly with respect to new Medidata product releases and/or offerings

  • Interface with Global Compliance and Strategy (GCS) to ensure business processes and controlled documents meet company and regulatory requirements

  • Support the development and delivery of training materials of PS processes and documentation

Your Competencies: 

  • Ability to work across numerous initiatives

  • Superior organization and communication skills, both verbal and written, with strong attention to detail

  • Excellent analytical skills 

  • Highly proficient in business process mapping skills

  • Strong business writing skills

  • Strong interpersonal skills and able to work in a cross-functional/matrix environment 

Your Education and Experience: 

  • Good experience authoring/developing/creating regulated documents such as Standard Operating Procedures (SOPs)

  • Good experience working in an enterprise content management system

  • Good experience with MS Office products, Word, Excel, Powerpoint

  • Good experience with Confluence, Smartsheet, Google Docs, Blueworks, Jira preferred but not required

  • Good experience with process documentation skills

  • Bachelor's degree required; or equivalent years of experience

  • 3+ years of professional work experience in a process development and/or quality or regulatory operations  

Note: The requirements should reflect your minimum requirements for the role in general


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 Solutions have powered over 20,000+ 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.