Business Analyst - IDMP - Ampcus Incorporated

Bravens Inc., a wholly owned subsidiary of Ampcus Inc., is an information technology consulting and services company. Bravens is a leader in providing tailored staffing solutions across both IT and non-IT industries. We are in search of a highly motivated candidate to join our talented team and contribute to our ongoing success.

Job Title: Business Analyst - IDMP (Identification of Medicinal Products (IDMP) Business Analyst)

Location(s): Chicago, IL (Hybrid)

• Veeva RIM, IDMP (Identification of Medicinal Products)
• You must understand implementation of IDMP using Veeva RIM

• Engage, as needed, in the internal activities tied to the application of XEVMPD data within the EMEA.
• Utilize the understanding of data requirements and processes for the transition to IDMP.
• Assist in formulating the IDMP strategy.
• Collaborate with colleagues to clarify the strategy and incorporate the needs and requirements from partner functions across Regulatory and various sections.
• Aid in multiple projects aimed at implementing the IDMP strategy within Company.
• Coordinate with the Business System Owner and IT counterparts, adhering to the principles of the System Development Life Cycle.
• Support the establishment and configuration of the IDMP Maintenance and Submission Tool, guarantee the accurate uploading of IDMP data into the tool, establish maintenance and submission methodologies with key stakeholders, and assist in the execution of operational tasks.
• Lead the Data Governance committee where cross-functional stakeholders work together to enhance internal data and systems in accordance with ISO IDMP and other internal use cases.
• Support the development of the internal Regulatory Data Hub to ensure it aligns with ISO IDMP concepts consistent with IDMP progress.
• Ensure coordination with IDMP-related subjects, including XEMVPD and the Digital Application Dataset Integration.
• Oversee non-EU IDMP-related initiatives.
• Communicate to the XEVMPD-IDMP Team Lead and Senior Management regarding the advancement of the IDMP program and projects.

• 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.

• 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 (engineering or scientific field, MBA).
• Years of Experience: 14.00 Years of Experience

Bravens is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.