Job order - J - Permanent Full Time Title Business Consultant - Regulatory Operations Category Business Consulting City UK Wide United Kingdom Job Description Business Consultant - Regulatory Operations
Position Description
Put your business insights to the test, helping unlock complex challenges and design solutions for tomorrow, today.
At CGI, our Business Consultants are trusted to work closely with a wide range of clients on exciting projects with real-world purpose and impact and 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.
CGI was voted a Best Workplace by Great Place To Work in 2021, and offers a competitive salary, excellent pension, private healthcare, plus a share scheme (3.5% + 3.5% matching) which makes you a member not just an employee. We are committed to inclusivity, building a genuinely diverse community of tech talent and inspiring more women to pursue careers in our sector. We won Best Tech Employer at the 2022 Women in Tech Employer Awards.
We are happy to discuss remote or hybrid working. At CGI youll be part of an open, friendly community of experts.
Well train and support you in taking your career wherever you want it to go.
Your future duties and responsibilities
As a Senior Consultant provide guidance for regulatory content, advise both client and internal teams where needed.
Provide SME support for Regulatory operations with dossier management, submission management, proven knowledge in identifying documents types and purpose per Health Authority requirements.
Provide guidance for word document formatting and/or template conversion, document level publishing activities for Clinical Study Reports.
Manage client relationships, communications and expectations by developing a communication process to keep teams up-to-date on project results.
Manage multiple projects, adjusting schedules when necessary; determining daily priorities; ensuring efficient and on-time delivery of project tasks and milestones; following proper escalation paths; and managing client and supplier relationships.
Focus on quality improvement and data management; contribute to develop process improvements
Collaborate closely with technology teams to implement solutions and requirements for client business problems. Provide necessary guidance on Regulatory functional areas to develop solutions as required.
Identify any risks/issues to the projects and follow up to resolve the issues with internal and external stakeholders.
Required qualifications to be successful in this role
Regulatory Operations and Regulatory Information Management experience
Knowledge of drug development and approval process within pharmaceuticals
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
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
Demonstrated ability to effectively collaborate with cross-functional virtual teams
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, as owners, we 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 todayone of the worlds 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 everyone belongs, and we collaborate with clients in building more inclusive communities. As an equal opportunity employer, we 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 CGIwhere your ideas and actions make a difference.
Skills Client Management Documentum SharePoint development 23229,0,25286,0,51264,0 > Reference