Regulatory Business Analyst

Waterville, ME

Contact Details

Job Description


Founded in 1976, CGI is a leading end-to-end IT and business consulting services provider. CGI’s Waterville center is the perfect mix of corporate opportunities and support with a small town feel, and one of CGI’s seven onshore delivery centers. Located in the heart of downtown Waterville, easily accessed by two exits off Interstate-95, CGI’s Waterville delivery center is the first such center in the area, aligning with the region’s economic and cultural revitalization goals. The center provides a broad range of services to clients throughout New England, including Data & Business Intelligence, application design and business services. Our office is located within walking distance of shops, cafes, restaurants, community parks, and the local farmers market. We embrace ongoing training, continued education, flexible hours, and an innovative tech-oriented work environment. Members participate in CGI social clubs and community outreach programs. CGI Waterville is passionate about CGI’s corporate mission, “To create an environment in which we enjoy working together and, as owners, contribute to building a company we can be proud of."

Our CGI Waterville Center is building a new eClinical solutions capability to support our Health and Life Sciences clients across the globe. We are looking for driven and motivated candidates to join our growing team and contribute to the success of our Center. If you want to learn new skills, grow professionally and be part of a great team then this position could be for you!

Our Center is looking for multiple candidates to fill our Regulatory Analyst roles. The Regulatory Analyst role is a business function activity with responsibility for performing regulatory analysis and cleanup activities on a variety of regulatory content including regulatory authoring (Administrative, CMC, Clinical and Nonclinical), submission archive and pharmacovigilance. The role includes communication between the Client Regulatory team and other members of the CGI team to elicit business rules, provide analysis against repositories, interact with the Client to confirm business rule application and obtain final approval of migration mapping specifications for migration into the target environment. Determine disposition classification of in scope and out of scope content and then further delineation of groupings of content such as HA Correspondence versus Submission documents, Clinical versus CMC content and deriving required metadata for content cleanup into a target environment within existing regulatory repositories.

FUTURE DUTIES AND RESPONSIBILITIES

Principle responsibilities for this role include the following activities:

• Working with the US Regulatory Team in partnership to complete client projects. Ensure communication is complete, accurate, and provide communication enhancements as necessary.

• Performs regulatory analysis and cleanup activities on applicable Regulatory Content

• Interface with both US and India based team members for knowledge and business rule transfer, process guidance, and key facilitation of communication between the India team and the US team.

• Ability to leverage existing regulatory knowledge to determine correspondence vs submission vs authoring vs pharmacovigilent content within existing repositories.

REQUIRED QUALIFICATIONS TO BE SUCCESSFUL IN THIS ROLE

Ideal candidates will meet the desired qualifications below. However, strong consideration will be given to candidates with transferable skills such as those in Business Analyst, Migration Analyst, Management Analyst, Regulatory Compliance Analyst and Research Coordinator roles along with experience in either of the following areas:

• Health & Life Science industries

• Research Coordination / Analyst

• Regulatory Compliance

• Compliance Management

• Medicare/CMS regulations

• Regulatory Info