Business Analyst - IDMP

Location : Hybrid - Chicago, IL - no flexibility (initially in office for a quarter, but potentially remote later)

BGV fully cleared

COG laptop

Must Have's :

Veeva RIM, IDMP (Identification of Medicinal Products)

Candidate must understand implementation of IDMP using Veeva RIM

10 years

Regulatory / Clinical domain

Some clients call this role a PM, but BA is the primary function

The Identification of Medicinal Products (IDMP) Business Analyst will hold an essential position in managing and leading the European rollout of the ISO Identification IDMP's standard within our Company. You will join a team advancing the strategic, project, and operational efforts related to regulatory data submitted to European authorities, encompassing IDMP / SPOR (European implementation of ISO IDMP), DADI (the substitute for the PDF electronic Application Form), and familiarity with XEVMPD (Extended EudraVigilance Medicinal Product Dictionary, or Article 57) is crucial for effectively transitioning to IDMP from both strategic and tactical viewpoints. You are also anticipated to address several non-EU related subjects.

Primary Activities include but are not limited to :

XEVMPD

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.

IDMP

Assist in formulating the IDMP strategy within our Company. Collaborate with colleagues throughout the Company to clarify the strategy and incorporate the needs and requirements from partner functions across Regulatory and various sections of the company.

Aid in multiple projects aimed at implementing the IDMP strategy within our 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.

External Activities

When the chance arises, represent our Company in European Industry Trade Association committees and meeting groups concerning IDMP. Assume leadership roles within the Trade Association committees and represent the industry in discussions and negotiations with health authorities and other stakeholders.

Qualifications, Skills and Experience :

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).

Years of Experience :

14.00 Years of Experience