Job summary: Vault RIM process and system is highly dependent on accurate develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team Applies skills and discipline knowledge to contribute to the achievement of work within Work Team Makes decisions to resolve moderately complex problems in standard situations Makes decisions within guidelines and policies Participates and contributes as a team member Qualifications: B.S./B.Scs.
is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
2+ years of experience in regulatory, data management, data governance, or a related role within the pharmaceutical or healthcare industry.
E2E general regulatory change management experience, including change initiation, performing impact assessments,
submission to HA and management of HA decisions/queries/interactions/commitments Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling Detailed understanding of GRS roles/responsibilities related to dossier maintenance and submissions Strong understanding of data governance principles and best practices.
Experience with master data management and data quality improvement.
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
Strong communication and collaboration skills.
Attention to detail and commitment to data accuracy and integrity.
EEO (Equal Employment Opportunity)