Associate Manager (Veeva Vault RIMS Expert)
We are seeking an Associate Manager (Veeva Vault RIMS) responsible for managing, configuring with support extended and maintaining the Veeva Vault platform to support the regulatory publishing and RIMS maintenance activities of ATNAHS’ markets within Pharmanovia. Our regulatory department is responsible for providing regulatory strategic advice and life cycle maintenance for the portfolio, globally. In addition, support with new product development initiatives.
Veeva Vault RIM and regulatory operations – Key responsibilities
Platform Managed Services
Veeva Release Management – Planning, Impact Assessment, Implementation, Validation & Testing, Documentation, coordinating with Veeva.
Training session & demo to the Pharmanovia team once Veeva releases have been released in Veeva and impact the end user.
Data Management Services
Manage creation and update to foundational data [Product, Product Family, Product Variant, Packaging] as per the defined data standards.
Monitor & Manage Data Quality within Vault proactively, based on pre-defined KPIs, identify corrective & preventive actions, agree with Pharmanovia stakeholders and support the implementation of data corrections.
Manage Volume Data Extraction requests from Vault and Content & Data upload requests into Vault.
Management of all electronic publishing systems and peripheral components which support those systems.
This individual assists with the development and maintenance of procedural and operational documentation related to Atnahs’ regulatory technology platform(s).
Cleansing large data sets from source destination in support of a system migration and to maintain a logging system / data quality plan.
To assign appropriate taxonomy and metadata to source data where required.
Maintain naming conventions and structure protocols and validate accuracy.
Incident Management
Day to day management & resolution of incidents.
Co-ordinating with Veeva for any platform or product level issues.
Propose lean processes to reduce and minimise the ticket issues raised by the team by up to 20% through training and trend analysis subject to user adoptability and implementation by Pharmanovia.
Change Management & Internal Release Management
Configure changes that are permissible to be implemented, such as workflows, lifecycle states, security, CVs.
Reporting & Dashboards
Creation of new reports, updates to existing reports as deemed necessary and/or on request from Pharmanovia.
Creation of dashboards, updates to existing dashboards as necessary and/or on request from Pharmanovia.
To work methodically with a keen eye for detail ensuring any data anomalies are highlighted.
Access Management
Control of access management of end user aligned with governance model for data management.
User Adoption Services
Support continuous user adoption of Vault RIMS Functionality.
Support on implemented functional processes within Pharmanovia Vault, either through Checklists or work instructions.
Training
Conduct regular monthly training with Veeva users on gaps/deficiency areas identified.
Providing ad hoc and on demand training.
Continuous Improvement
Support continuous improvement opportunities.
Quarterly updates with measurable improvements/opportunities that end users could utilise to increase efficiencies.
Qualifications& Essential Experience
4-7 years’ experience in regulatory publishing within Pharma, CRO, CMO, or similar organisations.
Veeva Vault configuration and administration
Regulatory data management and lifecycle processes
Document management systems in life sciences
Experience in GxP-regulated environments (GMP/GDP/GVP)
Experience working with SaaS/cloud-based platforms
Experience with eCTD publishing tools such as MasterControl, GlobalSubmit, EXTEDO, docuBridge, PharmaREADY, or eCTDXPress also considered.
Functional experience in Master Data Management (MDM).
Experience with regulatory submissions across US, EU, and SFDA markets.
Experience maintaining compliance, product lifecycle databases, and RIM systems.
Strong cross-functional collaboration skills.
Preferred
Experience in regulatory operations, submissions or publishing systems
Knowledge of system validation, testing and Agile methodologies
Veeva Vault certifications
What we offer (career development and working environment)
Competitive salary and benefits package.
Opportunity to develop specialist expertise in Veeva Vault RIM and regulatory operations.
Exposure to cross-functional projects and system improvement initiatives.
Support for relevant professional development and training.
A collaborative working environment focused on compliance, service and continuous improvement.
How to apply (application process and equal opportunities)
Please submit your CV outlining your relevant Veeva Vault RIM, regulatory affairs systems and regulated-industry experience. We are an equal opportunities employer and welcome applications from candidates of all backgrounds. Only shortlisted applicants will be contacted.