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Senior BA - Regulatory Operations / Life Science

Our client is currently seeking a Senior BA - Regulatory Operations / Life Science
Title: Sr Business Analyst (Regulatory Operations)
Duration: 6 Months CTH
Location: Plymouth Meeting, PA
Your future duties and responsibilities:
€ Responsible for delivering the regulatory and business related aspects of projects that are related to regulatory information and document management (including RIM/IDMP), regulatory operations, and other related projects.
€ Will need to develop and maintain strong relationships with existing clients and become attuned to potential business within the client.
Required qualifications to be successful in this role:
€ 5+ years of minimum Regulatory, Regulatory Operations, and information management.
€ Consulting experience, a plus
€ Business development experience a plus. Delivery experience
€ Client engagement and relationship building skills
€ Conceptual thinking as well as analytical and problem solving skills
€ Strong communication skills, both verbal and written, at all levels. Strong analytical skills.
€ Demonstrated ability to effectively collaborate with cross-functional virtual teams
€ Experience working with applications for projects and regulatory activities (e.g. InSight, Veeva, Documentum, SharePoint, etc).
€ Knowledge of Regulatory guidelines such as IDMP, US FDA, EU, ICH, GCP, GMP and ISO.
€ Knowledge of Regulatory (eDMS, Archive and RIM) systems including cross-functional usage requirements, business administration and best practices.
€ Knowledge of eCTD submissions and Regulatory documentation.
€ Knowledge of ISO IDMP elements and potential sources of IDMP information.
€ Experience in gathering and documenting requirements, Business Process Analysis, Change Management Concepts, Current/Future State Analysis
€ Full SDLC implementation experience
Desired qualifications/non-essential skills required:
€ Publishing experience and a thorough knowledge of regulatory submission content and electronic submission formats (i.e. eCTD, NeeS).
€ Experience working with applications for projects and regulatory activities (e.g. InSight, Veeva suite, Documentum, Sharepoint, etc).
Technical Skills:
€ Regulatory Operations - 5 year(s)
€ Analytical Thinking
€ Communication (Oral/Written)
€ Delivery Management
Judge Group Job Order ID: 566978
Salary: Open
Company Description:

Working at the crossroads of people and transformative technologies, The Judge Group delivers innovative business solutions €“ powered by top talent €“ to help organizations reach their strategic goals and realize opportunities now and in the future.


The Judge Group is a leading professional services firm specializing in technology, talent, and learning solutions. Our services are successfully delivered through a network of more than 35 offices in the United States, Canada, China, and India. The Judge Group serves more than 40 Fortune 100 companies and is responsible for the placement of more than 4,500 professionals annually across a wide range of industries. To learn more, visit www.judge.com.




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