Regulatory Consultant

Plymouth Meeting, PA

Regulatory Consultant

Category: Business Consulting, Strategy and Digital Transformation

Main location: United States, Pennsylvania, Plymouth Meeting

Position ID: J0324-1783

Employment Type: Full Time

Position Description:

The Regulatory Consultant will be a lead in driving and overseeing the delivery and consulting project within of CGIs key life science accounts and industry practices. Individuals filling the positions will have a unique opportunity to drive and assist in project and account growth. They will be responsible for strategic thinking and expert execution across the research organization including supporting their Regulatory Information Management portfolio of processes and systems serving Global Regulatory Affairs organizations and their partnering organizations. Partnering with business stakeholders as well as be a liaison with industry and business stakeholders to ensure activities are implemented to plans with Information integrity and according to defined requirements and timelines.

• This position will work with clients on both the business and IT organization to define, plan and execute strategic initiatives that will improve operational performance, increase profitability and create a competitive advantage. This role will lead initiatives across a variety of end-to-end solution offerings within the life sciences space.

We are looking for someone with the desire to drive innovation in the industry by collaborating with clients and industry partners to disrupt the current state of life sciences. This position will also be working with our industry leaders in building new capabilities and developing innovative ways for CGI to help its clients transform and grow.

Your future duties and responsibilities:

• Partners closely with our stakeholders to ensure fully integrated regulatory systems, experience and information model and externally facing capabilities.

• Improve quality of services, support colleagues and propagate knowledge and expertise

• Leverage engagement deliverables and project management experiences to form the basis of re-usable approaches and methodologies

• Lead and support development of market-leading capabilities related to area of expertise to support current and future needs within our Life Sciences clients

• Advise business stakeholders on mindset transformation and how their work will need to change to support the future.

• Serve as the bridge between the business and IT stakeholders to embrace technology as a tool to solve business problems.

• Support and guide clients to define, develop and plan various consulting engagements from short-term assessment projects to large-scale transformational initiatives.

• Define business needs and analyze complex problems. This includes but is not limited to scoping, requirements development, process development, communications, planning for individual efforts, managing, advising, overseeing implementations.

• Identify and document the needs of multiple stakeholders.

• Foster partnership with customers, stakeholders, sponsors.

• Qualifying opportunities and creating a strong business case to support recommendations..

• Build and maintain strong client relationships and develop business with assigned clients.

• Build and lead teams to foster individual and team development and expertise.

• Leverage CGI Operations Management standards to achieve targeted revenue and profitability.

Required qualifications to be successful in this role:

• Bring deep life science knowledge and delivery capability specifically around end to end Regulatory Operations (HRM, RIM, Submissions Planning, Publishing, Submissions Management), to be integrated into the market place and be responsible for bringing solutions and thought leadership to our clients, work well in collaborative environments, be highly motivated by delivering excellent services to our clients and ensuring their satisfaction.

• Will use and leverage your experience and creativity to design, propose and execute solutions for complex client problems in advanced business and technology environments.

• Manage client satisfaction in partnership with account management teams.

• Competency in Microsoft applications including Word, Excel, PowerPoint, MS Project, Visio.

• Strong experience with technology and IT organizations is important.

o (Agile / Scrum / Kanban principals)

• Strong Industry Practice knowledge in end to end Regulatory Operations (HRM, RIM, Submission

• Planning, Publishing, Submissions Management).

• System Implementation Experience with various industry vendors

Required Behaviors, Knowledge and Skills

• Lives up to the CGI Values: Partnership and Quality, Objectivity and Integrity, Intrapreneurship and Sharing, Respect, Financial Strength, Corporate Social Responsibility

• Demonstrates leadership: cultivates team spirit, provides direction and vision, displays integrity in action, fosters open communication

• Self-motivated with the ability to effectively multitask in a fast-paced environment.

• Minimum of 10+ years or equivalent experience in advising, defining, implementing and executing business processes change in the pharmaceutical industry, including an understanding of the drug development process.

• Experience with business systems use including content management systems, databases, business process management and electronic workflow/routing tools, regulatory submission, planning and tracking systems.

• Knowledge of application system management and change control processes, application validation and implementation in a GxP environment

• Knowledge of Pharmaceutical metadata and standards

• Demonstrated, in depth knowledge of Pharmaceutical drug development environment and regulations.

• Demonstrated customer relationship skills and capabilities and collaboration on teams.

• Demonstrated ability to perform in a cross-functional environment.

• Strong verbal, written communication and presentation skills.

• Ability to provide outstanding customer service, be a good listener and work well with others.

• Relevant project management delivery tools and techniques

• Analytical, problem solving, and conceptual thinking skills.

• Excellent written, verbal communication and negotiating skills, with customers, team and stakeholders

• Ability to influence stakeholders and work closely with them to determine acceptable future state offerings and solutions.

• Ability to effectively interface with technical and nontechnical staff at all organizational levels.

• Ability to learn new content areas and new skills quickly.

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, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, 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 for this role in the U.S. is $108,600 - $228,100.

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

#LI-CG1

#DICE

Skills:

  • Management Consulting

  • Life Sciences

  • Implementation Management

  • Regulatory Risk-Management

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, height, weight, 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 Position ID 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 Position ID will not be returned .

We make it easy to translate military experience and skills! Clickhere (https://cgi-veterans.jobs/) 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 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.