IT Project Manager - Regulatory Information Management - Ireland Remote - 16 month contract.
This position is a member of the Global RIM program that partners with Regulatory Affairs business areas to understand technology needs, ensure that global RIM processes are compliant and representative of the cross functional business needs. The successful candidate will demonstrate strong Regulatory Affairs domain expertise, provide business analysis including detailed requirements elicitation and IT project management experience.
Key responsibilities for this role include:
Perform duties as assigned on Global RIM project to support successful delivery of all needed phases (eg requirements elicitation and analysis, design, configuration, data migration and system integrations)
Monitor emerging regulatory agency requirements to assess business and system impact and develop the requirements to ensure compliance.
Collaborate with key business users to identify business needs and translate these needs to user requirements. Translate user requirements into technical requirements and implement solutions to meet these requirements.
Provide business analysis techniques including business and functional requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis.
May manage IT projects/project workstreams for Regulatory Affairs to implementation this includes coordinating activities of project personnel to ensure that the project successfully progresses in scope, on schedule and within budget.
Work with teams globally for end-to-end implementation of global RIM to ensure compliance with regulations by FDA, EMA and other health agencies.
Drive compliance with the IT Quality processes and SDLC processes, including the IT change management and quality/testing process.
Collaborate with solutions lead and business partners to ensure technologies are meeting business requirements.
Support the vendor relationship for RIM M&A and xEVMPD systems, ensuring that any system issues are communicated to leadership.
The minimum qualifications for this role are:
Hands on experience supporting and implementing Veeva Vault RIM Registrations platform is required. Veeva certification desired.
Prior experience in the pharmaceutical industry and a good understanding of regulatory processes, compliance and validation.
Experience with validated GxP environments including implementation, documentation, and change management is required.
Broad technical knowledge, including experience with SaaS in a regulated environment.
Experience with regulatory business processes such as submission planning and tracking, registration management, commitment management and content management.
Good business analysis and project management skills as well as attention to detail.
Ability to challenge requirements with key stakeholders to ensure requirements are detailed and properly defined.
Ability to operate in a challenging environment and manage multiple activities, priorities, and deadlines.
Excellent verbal and written communication skills.
Works well in and appreciates the value of a global diverse work environment.
Is able to see the larger picture and able to identify key issues in complex situations.
For a confidential discussion and more information on the role, please contact Aideen Cummins.
aideen.cummins@collinsmcnicholas.ie
071-9142411