CGI Technologies and Solutions, Inc. Sr Business Analyst - Regulatory Operations / Life Science in Plymouth Meeting, Pennsylvania
Sr Business Analyst - Regulatory Operations / Life Science
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Category:Business Analysis (functional and technical)
City:Plymouth Meeting, Pennsylvania, United States
Employment Type:Full Time
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You will have responsibility to manage regulatory consulting projects. This role will contribute positively to developing business relationships with clients and internal (client) stakeholder members
The Regulatory Business Process Consultant will be responsible for building, communicating and managing solutions involving life science business consulting services. It is critical that this resource have significant Regulatory Affairs/Operations business domain expertise. Larger domain knowledge across R&D is preferred.
Experience we need for this role: Regulatory Principal should possess strong analytical skills and detailed understanding of the business processes across regulatory functional areas. They objectively evaluate information gathered from multiple sources, reconcile conflicts, breakdown high level information into details, and abstract up low-level information to a general understanding distinguishing user requests from the underlying needs of the business. They provide direction, coordination, leadership and supervision to the project team members. This role should have 10+ years experience in Regulatory Affairs, Operations, or Intelligence areas of life sciences, or have completed a Masters program in Regulatory Affairs. A RAC certification is a plus.
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
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).
What you can expect from us:
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Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
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CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
We make it easy to translate military experience and skills! Click here at http://cgi-veterans.jobs/ to be directed to our site that is dedicated to veterans and transitioning service members.