Regulatory Business Analyst

Category: Business Consulting, Strategy and Digital Transformation
City: Waterville, Maine, United States
Position ID: J0819-1860
Employment Type: Full Time
jobimage

Meet our professionals

CGI: An employer of choice

Position 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, Clincial 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 v 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 Information Management

• Publishing

• Quality Assurance

QUALIFICATIONS

• 1-3+ Years’ experience in Regulatory Operations or related roles

• Technical aptitude to learn new systems as end users. Coding and system development experience is not required.

• Candidates will have an understanding of EU regulatory standards such as CP, MRP and DCP and National submission.

• Regulatory operations experience with dossier management, submission, and development.

• General understanding of the regulatory landscape in regards to submissions such as eCTD, non-eCTD and NeeS.

• Regulatory business experience and knowledge of the product approval lifecycle for product development to post marketing activities.

• Submission dossier experience with an ability to recognize documents types for submission to Health Authorities versus HA Correspondences versus submission supporting documents.

• Strong Excel skills

• Ability to learn new systems user interface quickly

• Proven experience working with a cross-functional US / India Team on projects

• Strong focus on quality; high attention to detail demonstrated through proofing, follow through and scheduling

• Thrives in a dynamic work environment balancing priorities for efficient workflow, particularly under tight deadlines

• Ability to work in a team-oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction as well as back-up colleagues as needed

• Self-motivated and striving for continuous self-improvement; actively engaging in self-directed learning related to professional development.

• Nice to have: working with applications for projects and regulatory activities (e.g. InSight, Veeva, Documentum, SharePoint, etc).

• Bachelor’s Degree from an accredited college/university or 3 years equivalent experience.

DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED

Desired Technical Skills:

• MS Office Suite (Word, Powerpoint, Visio, Outlook, etc.)

• Veeva Vault experience (nice to have)

Desired Business Skills:

• Domain experience in Pharmaceuticals, Healthcare, Health Insurance, Medical Devices

• Issue and Risk management

• Demonstrated problem solving skills

• Negotiating and Influencing skills

• Root cause analysis and identification

• Lean and Lean Six Sigma knowledge

• SAFe/ Agile knowledge



Minimum Education Requirement: Bachelors Degree or 3 years equivalent experience
#LI!-ML1

What you can expect from us

Build your career with us.

It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.

At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.

Be part of building one of the largest independent technology and business services firms in the world.

Learn more about CGI at www.cgi.com.

No unsolicited agency referrals please.

CGI is an equal opportunity employer.

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.

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 US_Employment_Compliance@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 to be directed to our site that is dedicated to veterans and transitioning service members.

All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held.

CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.

CGI is committed to the principles of equal employment opportunity and to compliance with US laws and regulations. Click here to access our US EEO/Affirmative action policy.

Applicants have rights under Federal Employment Laws:

  1. EPPA
  2. FMLA
  3. Consolidated EEO Is The Law

 

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 US_Employment_Compliance@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 to be directed to our site that is dedicated to veterans and transitioning service members.