JOB RESPONSIBILITIES

Responsibilities:

• Has fundamental understanding of XEVMPD, IDMP and other structured data requirements, regulations and telematic projects (e.g., SPL, PQ CMC, IRIS, ePI, DADI, etc.)
• Uses technical expertise and experience to deliver on complex tasks and identify new opportunities
• Develops and uses internal and external partnership networks to influence and improve the accomplishment of business goals
• Experience in registering XEVMPD and SPOR data
• Experience data validation & enrichment as per EMA guidelines for IDMP
• Knowledge & experience in the ISO guidelines related to IDMP
• Experience in the data catalogue, PMS database & data quality projects
• Coordinate operational activities to ensure compliance with regulatory obligations including XEVMPD and IDMP
• Coordinate data quality reviews to support business objectives (e.g., system data reviews, PSUSA/XEVMPD, and Annual Pharmacovigilance Fees)
• Lead projects, developing tactical approach including timelines, works plans and deliverables for moderately complex activity
• Design and implement new solutions through stakeholder partnerships, ensuring ability to maintain compliance and data integrity, continuously improving on those processes
• Develop approaches to support with data collection, transformation, mapping, and enrichment from and between documents and systems
• Develop operational and governance models to support readiness activities for new data focused regulatory obligations (e.g., IDMP)
• Uses technical expertise and experience to deliver on complex tasks and identify new opportunities
• Develops and uses internal and external partnership networks to influence and improve the accomplishment of business goals
• Coordinate operational activities to ensure compliance with regulatory obligations including XEVMPD and IDMP
• Coordinate data quality reviews to support business objectives (e.g., system data reviews, PSUSA/XEVMPD, and Annual Pharmacovigilance Fees)
• Lead and support projects, developing tactical approach including timelines, works plans and deliverables for moderately complex activity
• Design and implement new solutions through stakeholder partnerships, ensuring ability to maintain compliance and data integrity, continuously improving on those processes
• Develop approaches to support with data collection, transformation, mapping, and enrichment from and between documents and systems
• Develop operational and governance models for readiness activities for new data focused regulatory obligations (e.g., IDMP)
• Author, review and endorse global data standards through regulatory data governance frameworks to facilitate compliance with health authorities and produce advancements and efficiencies that will contribute to the portfolio moving at light speed

• Bachelor's Degree with relevant experience
• Knowledge of XEVMPD and IDMP
• Knowledge of European regulatory framework including structure and content of Summary or Product Characteristics (SmPC) and Chemistry Manufacturing and Controls (Module 3)
• Experience and competency with Regulatory software, including RIM applications (e.g., Ennov/Calyx RIM, Veeva Vault RIM) and document management systems (e.g., Documentum)
• Knowledge of technology applications, including Microsoft 365 Apps (e.g., Excel, PowerAutomate, Teams, SharePoint, etc.)
• Ability to collect, aggregate and map data from and between different documents and systems
• Strong influencing, engagement, and communication skills (presenting, written, verbal and non-verbal)
• Able to operate at pace with agile decision-making skills; use evidence and apply judgment to balance pace, rigor, and risk
• Ability to apply critical thinking through reasoned judgements that are logical and well-thought out
• Able to get challenged with an adaptive mindset, seeing them as opportunities to innovate and improve
• Demonstrated project and change management skills; competent illustration of processes, tools and techniques for planning, monitoring, and implementing multiple projects to established deadlines
• Demonstrated ability to take responsibility, solve problems and deliver in a challenging, fast-paced environment
• Demonstrated ability to function autonomously in a matrix environment, working independently with minimal input from peers

• Knowledge of other structured data requirements/regulations and EU Telematics projects (e.g., SPL, PQ CMC, IRIS, ePI, eAF PLM, etc.)
• Experience with coding in MedDRA
• Ability to work with large datasets, interpret data and draw insights to support data driven approaches, predict outcomes and measure effectiveness
• Knowledge of data analytics and visualization tools (e.g., Spotfire), etc.
• Demonstrated experience of influencing through data storytelling, with the ability to use data to inform on an idea, concept, or insight
• Able to identify and drive digital technology into all areas of a business. Further able to evolve the digital thinking by identifying connections of systems and data across the business

• Functional/Technical Skills - has the functional and technical knowledge and skills to do the job at a high level of accomplishment
• Acts Decisively - makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision
• Seizes Accountability -will stand up and be counted; doesn't shirk personal responsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment
• Change Agile - can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty
• Peer Relationships- can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers
• Influencing - Uses a range of effective communication styles and creates and inclusive environment with internal/external stakeholders to deliver goals and promote quality; uses diplomacy and tact and can diffuse high-tension situations comfortably.