IT Technical Leader

Requirement – IT Technical Leader

Location – Plymouth Meeting, Pennsylvania,

Position Description
CGI is seeking a seasoned technical leader join our growing team supporting life science clients through end-to-end solution offerings and professional services. The successful candidate must be able to work in a cross-functional environment and interact with representatives from CGI, and our end-clients. This technical lead manager will work at various CGI/ clients consulting and executing various life science business and IT initiatives from road map assessment architecture best practice phase implementations and go live.

Your future duties and responsibilities
The IT Technical Lead is accountable for the effective delivery of RIM capabilities and services supporting the US business with specific focus in system implementations. This technical lead partners with business teams to define and drive RIM capabilities to meet their specific strategic needs across new and integration work. This position will accelerate the RIM capabilities business through technology innovation and ensure that their information capabilities and operations are reliable. You will build strong partnerships with the our CGI internal team and external client teams globally to drive consistent adoption of RIM capabilities and innovation opportunities and launch excellence.

Required qualifications to be successful in this role

• 10 years’ experience working with life sciences companies
• System implementation experience either as a consultant, business, or IT representative for at least one of the following systems: Document Management (Documentum, OpenText, SharePoint), Registration Data Tracking Systems, XEVMPD, IDMP, SPL, eCTD
• Labeling, Submission Publishing and/or Viewing systems
• In-depth knowledge of drug development processes and regulatory submissions
• Proven ability to collaborate with diverse stakeholders and ensure delivery to a high degree of satisfaction
• Excellent communication skills – written, verbal and formal presentation
• Influential; experience leading teams through hard decisions and negotiating compromises
• Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution
• Expert on life sciences compliance and computer systems validation requirements
• Ability to work independently in a fast-paced environment

Nice to Have

• Direct experience with systems such as Veeva Vault, PAREXEL/ LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc.
• Experience with data models, data lakes, data warehouses; designing information structure, and dataflow Cognos Reporting tools, workflow tools (Appian, TIBCO, Active Matrix, Uipath), and API frameworks (Apigee)
• Experience with Data Analytics
• Experience with BI visualization products (Qlik Sense, PowerBI, Spotfire)
• Experience working with on premise, Cloud capabilities, and software as a service (SaaS)
• Consulting experience, working with a major system integrator or software vendor
• Regulatory Affairs, Regulatory Operations or Pharmacovigilance background
• Knowledge of Medical Device and Diagnostics regulatory processes, data, and content
• Execution experience with Agile methodology and/or ACP Certification
• Life Science, computer science, or related degree

Skill Set Years of Experience Proficiency Level
IT Technical Partner 10 Expert
Consulting/Domain Experience 5 Expert
RIM / ECM / IDMP combination
of the above platform 5 Expert

Education: Bachelor's Degree

Job Types: Full-time, Part-time, Contract

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Levittown, PA: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Work Location: Multiple Locations