Regulatory Operations Analyst job vacancy

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CGI USA - Finding Balance

Position Description: As a Regulatory Operations Analyst, 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 Regulatory Operations Analyst 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).• Experience and familiarity working in an Agile/Scrum Framework and Jira (Configuration, EPICs, Tasks). Improving existing processes in backlog prioritization and eliminating bottlenecks.• 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.• Technology Management: Improving quality of services, understand possibilities of synergies in reusable approach and methodologies, and make sure to align to business client strategies• 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 / SDLC• Business development experience a plus• Demonstrated ability to effectively collaborate with cross-functional virtual teams

Skill Set Years of Experience Proficiency LevelRegulatory Operations - Publishing or other 3-5 Very GoodRegulatory Information Management 3-5 Very GoodConsulting 2+ GoodRegulatory Systems/Applications 3-5 Very GoodClient Communications/Interactions 2+ Good

DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED

Coaching and MentoringProject ManagementMicrosoft suite - PowerPoint, Excel, Word

Skill Set Years of Experience Proficiency LevelMicrosoft 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 $74,600.00-$146,900.00. We offer a competitive compensation package where you'll be rewarded based on your performance and recognized for the value you bring to our business. In addition, our benefits package includes multiple medical, dental, & vision options, both a Shared Purchase Plan (SPP) for CGI stocks and a 401(k) plan, as well as numerous other lifestyle benefits. CGI also provides sick leave and vacation pay.#LI-CG1#DICE

Skills:

Business Analysis
Life Sciences
Regulatory Risk-Management
Requirements Analysis

What you can expect from us:

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 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. 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.

ID: #49460965
State: Pennsylvania Plymouthmeeting 19462 Plymouthmeeting USA
City: Plymouthmeeting
Salary: USD TBD TBD
Job type: Permanent
Showed: 2023-03-13
Deadline: 2023-05-11
Category: Et cetera