CGI Technologies and Solutions, Inc. Lead Business Analyst Regulatory in Philadelphia, Pennsylvania
Lead Business Analyst Regulatory
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Lead Business Analyst Regulatory
Category: Business Analysis (functional and technical)
City: Philadelphia, Pennsylvania, US United States
Position ID: J0421-0572
Employment Type: Full Time
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; etc.).
From an oversight perspective, the Lead Business Analyst in Regulatory Operations will ensure the following activities are carried out:
Ensuring the regulatory documentation is consistent with agreements and applicable SOPs, as well a GCP regulations and ICH Guidelines.
Scanning supporting documentation, including identification defining the original record and reconciling copies, analysis of data elements, records management, indexing and scanning.
Uploading of electronic documents (including email correspondence / attachments), adding metadata, and performing quality checks on documents in the registrations and submissions functions
Conducting testing or verification of the system and/or processes, as needed
Responding for audit search requests
Supporting records management, retention and litigation requests.
Reconciling and remediating paper records
Collaborating with client delivery teams regarding project deliverables review and management.
Addressing requests in a timely and efficient manner.
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.
Working with users to identify and manage study expected document lists.
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 skills
• 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
•Years of Experience
DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED
• Experience with Veeva Vault or similar Content Management software platforms
• 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 knowledge
• Experience with enterprise requirements management / application lifecycle management tools
• Knowledge of the end to end regulatory and labeling processes
• Understanding of how functional (regulatory, clinical, non-clinical, CMC, labeling, etc.) artifacts and data sets are used by Regulatory Affairs / Regulatory Operations business processes
• 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 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 child care, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more
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, 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 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 .
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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. Qualified applicants with arrest and conviction records are welcome to apply.
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.