Position: Community Manager

Location: Remote Role

Job Description:

• Inviting applications for the role of Senior Manager, Regulatory Information Management!
• Within our Global Regulatory Affairs business, we are excited & committed to build an industry leading Regulatory Information Management & Governance capability to help our clients deliver medicines faster to patients. With the sky as the limit, we are passionate, resilient, and relentless in our pursuit.
• As an expert in regulatory information management, you will have the opportunity to be a part of a passionate group and help our esteemed clients achieve data drive transformation.

Main Responsibilities include:

• Provides expertise and leads delivery of projects involving implementation and/or management of Regulatory Information
• Drives Data & Content Migration into Regulatory Information Management System, involves:
• Source to target data model mapping
• Data quality assessment
• Recommend / identify / facilitate agreeing on data standards for new RIMS and data migration – naming convention, reference data standards, master data standards
• Identify, lead and execute data transformation & enrichment activities
• Document E2E Migration Strategy and associated documentation

Drives implementation of new RIMS platform:

• business requirements elicitation – providing subject matter expertise to drive harmonized functional requirements strategy with SMEs and stakeholders
• working with the implementation team to ensure the requirements are adequately implemented
• supports SMEs & stakeholders with functional & user acceptance testing
• supports change management – stakeholder engagement plan, communication plan, and roll out of new RIMS platform and continuous adoption within the business user community

Drives continuous improvement of existing RIMS platform:

• Data Harmonization, Implementation of data standards
• Data Quality Framework to identify & address data quality issues
• Identify and support implementation of automation opportunities, such as leveraging Robotic Process Automation, Artificial Intelligence
• Drives data alignment between RIMS and other systems (Clinical, Supply Chain, etc.)
• Working with product roadmap to ensure changing requirements are addressed

Leads offshore project delivery teams:

• Ensuring project team is onboard and aligned to the project expectations
• Ensuring business requirements are defined with precision & quality, driving execution in partnership with offshore delivery lead when applicable
• Create a motivating & inspiring environment, foster innovation, ideas and quality

Supports IDMP implementation

• Understanding of EU Implementation Guide, mapping to sources (M3, SMPC, eAF, RIMS, others)
• Identifying data transformation and correction needs for IDMP readiness
• Supports data readiness, business process readiness
• Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders – ability to articulate complex scenarios succinctly and targeted to the group
• Ensure customer success throughout the engagement

Minimum Qualifications

Bachelor's degree required in science, engineering or related field (advanced degree preferred)

Preferred experience and skills

• Relevant experience in the field of Regulatory Information Management within the Pharmaceutical Industry
• Expertise with Regulatory Information Management Processes – Registrations Data Management, Submission Planning, Submission Content Planning, Content Management, Submissions Publishing, Labeling Management
• Supporting implementation & maintenance of Regulatory Information Management Systems
• Supporting data migration, data assessment, data enrichment, data transformation and data readiness in the context of Regulatory Information Management System
• Reasonable understanding of Regulatory business processes – Marketing Authorization Applications, License Renewals, Variations, Labeling Submissions
• Experience defining & implementing data standards within RIMS – naming convention, reference data standards, master data standards
• Good understanding & experience with Veeva RIMS, data model and processes
• Experience with multiple RIMS platforms is an advantage: Veeva, Generis, Liquent Insight, Aris Global’s LifeSphere, Amplexor
• Experience with Document Management systems – Documentum, FirstDoc, etc.
• Experience with analyzing regulatory information, designing and developing reports, visualizations on BI platforms such as Spotfire, Power BI, Qlik Sense, etc.
• Knowledge of ISO IDMP Standards, SPOR & EU Implementation Guide, xEVMPD, PQCMC is an advantage
• Ability to drive adoption of new RIMS platform within business community
• Effective communication, presentation and interpersonal skills, ability to collaborate and engage effectively with the entire eco system (customer, vendor, ***)
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines
• Expert on life sciences compliance and computer systems validation requirements