Principal Consultant, Regulatory Information Management Systems
Owns the delivery of Regulatory Information Management (RIM), Regulatory systems processes and data standard-related projects (such as for IDMP) including but not limited to RIM / IDMP, etc. Strategy & Planning, Process Design, Vendor Selection & Implementation, Change Management, Data / Process / System Governance initiatives.
CDMs are critical to successfully growing PharmaLex by creating predictable and efficient project plans, communications, deliverables, and processes to support our customers’ needs. The role requires a multi-disciplinary approach to problem solving across process, people, data, and technology. This role will be expected to provide RIM / Regulatory / Data Standard subject matter expertise and interact and build relationships mostly with internal subject matter experts, business process owners, throughout PharmaLex to make things happen. The ability to understand and translate business needs into a future vision for RIM / Data Management from a strategic level down through defining business processes, and requirements and ability to adhere to and champion processes are essential.
Your Job
- Accountable for ensuring we are confident in the recommendations or solution offered and that it can be delivered to scope, time, cost, and quality.
- Accountable for creation and maintenance of project start up documents with contributions made from across the functional PharmaLex teams e.g., User Requirement Specification.
- Accountable for the execution and monitoring of the delivery project plan ensuring tasks, timelines, resources, and dependencies are clearly defined and known across the client and Phlexglobal project team.
- Accountable for managing any risks and issues, taking ownership of minimising risk and closing out issues promptly and satisfactory relating to delivery projects.
- Accountable for effective project delivery to meet the client needs as per client approved documentation.
- Accountable for producing high-quality deliverables that are well-received by the client.
- Contributor to continuous process improvement and for developing reusable assets for future projects.
- Contributor to pre-sales support working with Business Development, including input into proposals and contracts.
- Actively participates in the Business and Systems Consulting Team, sharing and re-applying skills and knowledge and bringing in best practice.
Skills & Requirements
To succeed in this role, you will be customer centric seeking to understand and advocate for the customer’s needs and have/or be willing to become proficient in PharmaLex’s products and services to confidently advise customers. The ability to understand and translate business needs into strategic vision, future business processes, user and functional requirements and ability to adhere to and champion processes are essential. Additional skills and experience are listed below:
- Proven history of working in a customer facing role, leading, and managing Regulatory business systems-related projects and programs
- Experience using various project, product and program management including Agile, Waterfall, etc.
- Experience providing business and data analysis services to enable greater Regulatory efficiencies, compliance, and innovation
- Experience working with cross-functional teams
- Ability to manage influence through persuasion, negotiation, and consensus building
- Experience facilitating several types of workshops (e.g., defining a RIM future state vision, defining future processes and requirements for RIM and/or IDMP data management)
- Experience developing project deliverables (e.g., current state assessment, RIM strategy & roadmap, process maps, SIPOCs, URS, FRS, project management plans)
- Experience using and implementing Regulatory systems (e.g., Veeva RIM, LIQUENT InSight, Documentum for Life Sciences, Generis, Ennov)
- Extensive knowledge of Regulatory business processes, content, and data
- Flexible approach, able to operate effectively with uncertainty and change
- Driven, self-motivated, enthusiastic and with a “can do” attitude
- Demonstrated desire for continuous learning and improvement
- Excellent communication and presentation skills
- Preferably educated to degree level, relevant industry experience will be considered
- Ability to travel to customer meetings and be flexible working across time zones
- Ability to travel internationally and be flexible working across time zones
About the company
PharmaLex is one of the leading service companies for the pharmaceutical industry globally and is specialized in all aspects of drugs and medical devices approval, of the development to market and any action of effective product maintenance. PharmaLex values includes international mindset, growth & learning, collaboration, quality focus, dynamic working approach and integrity & respect.
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