What are the responsibilities and job description for the IDMP - xEVMPD Consultant position at iTech US, Inc.?
Job Details
Company: iTechUS, Inc.
Job Title: IDMP/ xEVMPD Consultant
Location : Hybrid - Chicago, IL - no flexibility (initially in office for a quarter, but potentially remote later)
Job Responsibilities:
- 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.
Required Skills :
More than 10 yrs experience on IDMP/ xEVMPD with overall 20 plus yrs exp in total - more towards consulting. Candidate will need to be able to drive workshops and guide customers
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.
Required Education : At least a Bachelor s Degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems or closely related field is required.
Necessary Skills : IDMP, xEVMPD, VEEVA , RIM, Regulatory Affairs, Regulatory Operations, ISO, SPOR
To Apply :
Varsha Tarange
iTechUS, Inc.
