Global Regulatory Content Specialist
hace 10 horas
Lilly, a global healthcare leader, is seeking a dedicated individual to join its team as a Global Regulatory Content Specialist. This role will play a vital part in supporting affiliate regulatory and business alliance partnerships within the International Region, focusing specifically on the Latin-American market.
Key Responsibilities- Serve as a Subject Matter Expert for global regulatory business processes and their execution within the Veeva Vault RIM system to ensure consistency and accuracy.
- Support affiliate regulatory and alliance partnerships with Veeva Vault RIM submission management.
The ideal candidate will possess a high level of technical expertise in RIM and have excellent analytical and problem-solving skills. They should be able to effectively communicate complex information to various stakeholders and collaborate with cross-functional teams to drive process improvements.
Technical ProficiencyTo excel in this role, the successful candidate must achieve a high level of technical and practical proficiency with Veeva Vault RIM. They should stay up-to-date on system upgrades and make recommendations for configuration changes to support business process enhancements.
RIM Content Planning and Post-Approval Submission CoordinationThe Global Regulatory Content Specialist will support Affiliate Regulatory/Alliance Managers in planning RIM content for all submission types and manage post-approval submission plans for assigned countries/regions. This includes monitoring plans, workload, and timelines to ensure compliance and meet submission deadlines.
Affiliate Regulatory RIM System SupportIn this capacity, the specialist will work closely with Lilly's international affiliates to ensure they are equipped with the necessary tools and training to effectively utilize the RIM system.
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