Experience Level: 10+ years

Note: Only locals in Chicago, IL

Must Have's:

• Veeva RIM, IDMP (Identification of Medicinal Products)
• Candidate must understand implementation of IDMP using Veeva RIM
• Regulatory/ Clinical domain

Qualifications:

• A bachelor's degree in a science or information technology discipline is required.
• Extensive experience in Regulatory Affairs or Regulatory Operations.
• Hands-on knowledge and experience with ISO IDMP or IDMP/SPOR.
• A solid grasp of System Development Life Cycle methodology and the criteria for validating information management systems.
• Proven understanding of drug development and the execution of regulatory program strategies within countries and how this affects regulatory information management strategies.
• Experience as a leader on cross-functional teams, capable of influencing and motivating team members and Senior Management leading to high-quality and timely achievement of project goals.
• Evidence of situational leadership and innovative problem-solving within organizations and teams.
• Capability to prioritize personal responsibilities across multiple ongoing projects.
• Capability to lead through influence and collaborate effectively in matrix organizational frameworks.
• Capability to grasp details while maintaining an overarching "big picture" perspective of projects.
• Desired Experience and Skills
• Strong knowledge of XEVMPD/Article 57, potentially with experience in implementing or assisting with reporting tools and processes.
• Proficiency in project management methodologies and related toolsets.
• Advanced degree preferred (engineering or scientific field, MBA).