Lead Business Analyst Regulatory
Company: CGI Group, Inc.
Posted on: May 5, 2021
Lead Business Analyst Regulatory
CGI is seeking a Lead Business Analyst in Regulatory Operations
with > 5 years of direct experience in electronic Regulatory
Operational work (e.g. Submissions, Publishing, Data Migration,
Labeling, Process Analyses). This candidate will join CGI's Life
Sciences Industry Practice within our Regulatory/Clinical Tower.
They will bring to bear their subject matter expertise in support
of regulatory operations and technology platform implementation
projects across CGI clients, and will have the opportunity to
mentor junior analyst and account team members on Regulatory
Operations tools and processes.
The candidate must have experience leading work streams and/or
projects in GxP environments. He or she must be comfortable and
proficient in interacting directly with clients on an ongoing basis
and managing their expectations.
Your future duties and responsibilities
The Lead Business Analyst in Regulatory Operations will be
responsible for leading a team of Business Analysts and interacting
with client stakeholders / functions to support the management of
regulatory documentation and maintain inspection readiness and
submission compliance within the applicable systems. He/she will
identify high-impact areas of risk and continuous improvement
opportunities and create related remediation plans.
Additional responsibilities include assisting business clients with
developing new business processes or modifying existing business
processes (during implementation, developing communication
material; defining supporting procedures and standards; documenting
training materials; assisting in the immediate training effort;
From an oversight perspective, the Lead Business Analyst in
Regulatory Operations will ensure the following activities are
1. Ensuring the regulatory documentation is consistent with
agreements and applicable SOPs, as well a GCP regulations and ICH
2. Scanning supporting documentation, including identification
defining the original record and reconciling copies, analysis of
data elements, records management, indexing and scanning.
3. Uploading of electronic documents (including email
correspondence / attachments), adding metadata, and performing
quality checks on documents in the registrations and submissions
4. Conducting testing or verification of the system and/or
processes, as needed
5. Responding for audit search requests
6. Supporting records management, retention and litigation
7. Reconciling and remediating paper records
8. Collaborating with client delivery teams regarding project
deliverables review and management.
9. Addressing requests in a timely and efficient manner.
10. Training on and driving understanding of all technical aspects
of applicable regulatory system(s) and associated tools, including
work instructions, metrics timelines, and relevant processes.
11. Supporting Audits/Inspections.
12. Working with users to identify and manage study expected
13. Supporting business user questions.
Required qualifications to be successful in this role
--- Bachelor's degree OR equivalent work experience
--- Experience in GxP Operations / Environments
--- 5+ years direct experience in managing paper / electronic
submissions and/or registrations
--- Excellent oral and written communication and interpersonal
--- Highly organized
--- Ability to analyze, articulate and solve problems
--- Ability to learn quickly, move with agility between
assignments, multi-task, and to work effectively in a team
environment, both face-to-face and remotely
--- Skill Set
--- Years of Experience
--- Proficiency Level
DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED
--- Experience with Veeva Vault or similar Content Management
--- Experience using electronic document management system
--- Experience executing any role within the SDLC (including
author, analyst, tester, coordinator, or project manager)
--- Requirements development, engineering or management
--- Experience with enterprise requirements management /
application lifecycle management tools
--- Knowledge of the end to end regulatory and labeling
--- Understanding of how functional (regulatory, clinical,
non-clinical, CMC, labeling, etc.) artifacts and data sets are used
by Regulatory Affairs / Regulatory Operations business
--- Knowledge of electronic document management applications (e.g.,
Documentum, SharePoint, Livelink) preferred
--- Knowledge of ICH and local regulatory authority drug research
and development regulations preferred.
--- Knowledge of eCTD/NeeS industry accepted standards, such as the
DIA TMF Reference Model
--- Analytical / logical, with superior attention to detail and an
inclination to spot patterns and outliers.
--- Be able to demonstrate a flexible, proactive, diligent and
self-motivated approach to work
Est. Salary Range (Colorado Only): $66,000-$120,000*
*Disclaimer: In accordance with Colorado's Equal Pay for Equal Work
Act, effective January 1, 2021, a good faith hourly or base salary
range must be posted for all positions where the work may be
performed in the state of Colorado. Therefore, this good faith
salary range will only apply where this described position will be
performed in the state, and should not be considered the
compensation range in other locations or for other positions.
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
--- 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 child care, Pet insurance, a Member Assistance Program,
a 529 college savings program, a personal financial management
tool, lifestyle management programs and more
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
Be part of building one of the largest independent technology and
business services firms in the world.
Learn more about CGI at .
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 . 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
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
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.
Keywords: CGI Group, Inc., Philadelphia , Lead Business Analyst Regulatory, Professions , Philadelphia, Pennsylvania
Didn't find what you're looking for? Search again!