Business Analyst -(IDMP) Identification of Medical Products

About Us:
Cognizant (Nasdaq: CTSH) is one of the world's leading professional services companies, redefining clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. We help our clients modernize technology, reinvent processes, and transform experiences, so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at www.cognizant.com or @cognizant.

Role: Business Analyst - Identification of Medical Products (IDMP)

Job Summary:
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.

Responsibilities
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 client. 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 client.
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.

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).

Salary and Other Compensation:
Applications will be accepted until January 28, 2025.
The annual salary for this position is between $66,896-$153,000 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
* Medical/Dental/Vision/Life Insurance
* Paid holidays plus Paid Time Off
* 401(k) plan and contributions
* Long-term/Short-term Disability
* Paid Parental Leave
* Employee Stock Purchase Plan
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.