We have a requirement for a Senior Business Consultant for one of our Federal Government clients.
Mandatory Requirements:
- Must have a minimum of ten (10) years of experience in information technology (IT) related systems.
- Must have a minimum of ten (10) years of experience in integrating electronic information management systems with existing business operations for business units of hundred (100) people or more
- Must have experience in at least three (3) projects for a large organization(s) (250+ personnel) within the past ten (10) years with gathering and documentation of business and functional requirements.
- Must have a minimum of ten (10) years of experience in development and management of project plans, including timelines, deliverables, milestones and costs for information systems.
- Must have a minimum of three (3) projects within the past ten (10) years demonstrating strong oral and written communications skills in meetings and presentations for senior management.
- Must have current certification in project management (e.g. PMI) or service delivery (e.g. ITIL) or management consulting (e.g. CMC)
- Must have a minimum of three (3) years demonstrated experience with MS Project, MS Office (any version) and Adobe Acrobat Professional.
- Experience in successfully integrating electronic information management systems with business operations.
- Experience within the past ten (10) years gathering and documenting business, functional and security requirements.
- Experience in development and management of project plans, including timelines, deliverables, milestones and costs.
- Experience with Electronic Standards for the Transfer of Regulatory Information (ESTRI) gateway protocols and standards.
- Experience working with ICH Individual Case Safety Report (ICSR), XML message standards (ICH M2 Document Type Definition (DTD) of the Electronic Transmission of Individual Case Safety Reports message Specification.
- Experience in the past five (5) years with integrated IT systems with the Government of Canada (GC) Internal Credential Management (ICM) public-key infrastructure and/or the GC External Credential Management (ECM) identity management shared services for authentication and secure communication of Protected B information.
- Experience in the past five (5) years with the implementation of business systems that use electronic signatures.
- Experience in the past five (5) years with structured documents and forms to capture and transfer information using XML.
- University Degree in Computer Science or Business Information Systems.
- Experience in a health or regulatory organization.
- Gather and refine high level business requirements for the E-Review 2.0 project;
- Conduct business analysis of the business requirements and recommend alternative options to meet business requirements in a timely fashion;
- Develop and document statements of requirements, and cost/benefit models for identified alternative options;
- Perform business analysis of functional requirements to identify information, procedure, and decision flows;
- Provide advice on the implementation and deployment of the E-Review 2.0 project deliverables for the Therapeutics Products Directorate (TPD), Biologics and Genetic Therapies Directorate (BGTD), Veterinary Drugs Directorate (VDD), and other Directorates in the HPFB;
- Research, document, analyze and compare Electronic Regulatory Activities (ERA) solutions adopted by other national and international regulatory organizations as applicable;
- Liaise with, and provide support to, the Group on Electronic Regulatory Activities (GERA) representing a broad base of stakeholders from all areas of the HPFB and regulated industry; and
- Prepare reports, briefings and presentations on the E-Review 2.0 project vision, strategy, design, business case, and plan, as required.
Duration: 1 year (Option of 1 year)
Type: Contract
Location: Ottawa
Salary: TBD
Experience: 10 years
