IT Business Analyst – Regulatory Operations
As an IT Business Analyst – Regulatory Operations, you will have responsibility to manage and deliver on regulatory operations projects. You will be working alongside seasoned consultants and subject matter experts to ensure that all client deliverables meet customer expectations. You will be expected to actively contribute to business transformation, process optimizations and solution design. This role will contribute positively to developing business relationships with clients and internal (client) stakeholder members.
Your future duties and responsibilities
The IT Business Analyst – Regulatory Operations, will be responsible for delivering regulatory and business-related aspects of projects concerning regulatory information and document management (including RIM/regulatory systems), regulatory operations, and other related projects. They will also 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 Regulatory Operations and Regulatory Information Management experience.
• Knowledge of drug development and approval process.
• Strong understanding of global R&D submission process and requirements including eCTD publishing principles and various application types (IND/CTA, NDA, MAA, NDS etc)
• Knowledge of Global Regulatory guidelines and Processes (US / EU / APAC / etc.)
• Demonstrated Consulting experience, preferred.
• Experience working with applications for projects and regulatory activities (e.g. InSight, Veeva, Documentum, SharePoint, etc).
• Knowledge of Regulatory (eDMS, Archive and RIM) systems including cross-functional usage requirements, business administration and best practices.
• Experience in gathering and documenting requirements, Business Process Analysis, Change Management Concepts, Current/Future State Analysis.
• 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
• Business development experience a plus
• Demonstrated ability to effectively collaborate with cross-functional virtual teams
Skill Set Years of Experience Proficiency Level
Regulatory Operations – Publishing or other 3-5 Very Good
Regulatory Information Management 3-5 Very Good
Consulting 2+ Good
Regulatory Systems/Applications 3-5 Very Good
Client Communications/Interactions 2+ Good
DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED
Coaching and Mentoring
Microsoft suite – PowerPoint, Excel, Word
Skill Set Years of Experience Proficiency Level
Microsoft Suite 3+ Good
Minimum Education Required: Bachelor's degree
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to: skill set level; experience and training; and licensure and certifications. CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $84,000-$176,300.
At CGI we call our professionals "members" to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI's benefits include:
• Competitive base salaries
• Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category
• 401(k) Plan and Profit Participation for eligible members
• Generous holidays, vacation, and sick leave plans
• Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment.
• Back-up childcare, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more
Insights you can act on
While technology is at the heart of our clients' digital transformation, we understand that people are at the heart of business success.
When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees "members" because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today – one of the world's largest independent providers of IT and business consulting services.
At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.
Ready to become part of our success story? Join CGI – where your ideas and actions make a difference.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, 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.
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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 consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
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.
- Business Analysis
- Life Sciences
- Regulatory Risk-Management