Location: Charlotte,NC, USA
We are seeking an experienced Project Lead to manage and oversee the data loading process into TIRKS (The Integrated Regulatory Knowledge System). You will lead cross-functional teams to ensure the successful extraction, transformation, and loading (ETL) of regulatory submission data, ensuring compliance, data integrity, and alignment with regulatory standards.
Key Responsibilities:
Lead the planning, execution, and delivery of data loading projects into TIRKS, ensuring timely and accurate data integration.
Manage cross-functional teams (Regulatory Affairs, IT, Data Management) to coordinate and implement data loading processes.
Ensure data accuracy, integrity, and compliance with regulatory guidelines (FDA, EMA).
Define data mapping and transformation rules for consistent integration across systems.
Oversee the quality assurance process, conduct regular audits, and resolve data discrepancies.
Provide project updates to stakeholders and manage risks, issues, and timelines.
Identify and implement process improvements for data workflows and TIRKS functionality.
Qualifications:
Education: Bachelors degree in Life Sciences, IT, Regulatory Affairs, or related field. Project management certification (PMP) is a plus.
Experience: 5+ years in data management or regulatory affairs, with 2+ years of project leadership experience in data loading or system integration (TIRKS preferred).
Skills: Strong project management, leadership, and communication skills. Expertise in ETL processes and regulatory compliance.
Technical Skills: Familiarity with TIRKS or similar systems (e.g., Veeva, Documentum), and proficiency in data tools (SQL, Excel).