Senior Regulatory Systems & Strategy Manager

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Background

Exciting opportunity to join a major programme of work managed by Cognizant for a major global client. You will work closely with the Regulatory Systems & Strategy (RS&S) Associate Director to ensure xEVMPD and IDMP/SPOR related submissions according to evolving regulatory requirements.

Essential Criteria must be clearly demonstrated on CV

• In depth experience within the pharmaceutical industry in a regulatory environment and closely related areas (e.g., Clinical Development, GxP, Regulatory CMC, QA, Project Management).
• Commercial experience with Veeva Vault platform.
• Life Science Degree (e.g., Chemistry, Pharmacy, Biology), or MBA (Project Management)

Also essential

• Understanding of health authority regulations/guidelines and IDMP specific (e.g., EU IG, FDA regulations, ICH and EMA guidelines/directives.
• Previous experience performing critical review of ISO IDMP documents in EU and other regions to facilitate adoption according to company's position.
• Review and prepare User requirements for systems improvements
• Strong communicator.
• Project management experience.

Accountabilities

• Support IDMP/SPOR data readiness portfolio via necessary updates in xEVMPD or PMS UI to secure PLM eAF variations and EU requirements.
• Support data verification of product data migrated to MDM in alignment with current RIMS and DMS.
• Support MDM system process implementation and improvements.
• Support optimal use of SPORIFY for Referentials/Organisations/Substances mapping to SPOR and other external standards.
• Contribute to the technical assessment of upcoming IDMP requirements/guidance documents in EU & non EU regions and propose current systems or process changes as relevant.
• Contribute to communication platforms and training initiatives to raise awareness on IDMP requirements and Data Governance principles within and outside RA

Key Performance Indicators

• Oversight of timely delivery and tracking of upcoming PMS submissions/activities to ensure compliance with high-quality data.
• Ability to drive knowledge sharing and process improvements across RA teams.
• Ensure timely, high-quality and consistent use of RDM/MDM for lists/terms/entities in scope, with appropriate documented review and QC process.
• Lead and support the mapping of relevant lists/terms with consumer and external systems with impacted functions.
• Contribute to upcoming testing activities (UAT, pilots) within Regulatory Systems & Strategy (RS&S).
• Provide effective support in preparation of SOPs, Working Instructions and Best Practices to support system implementations or updates.
• Demonstrate strong level of customer orientation to deliver best quality on time with adequate level of detail. Leverage requirements and find the right balance to ensure compliance with HA requirements and company benefits.
• Develop relevant trainings to ensure compliance with upcoming ISO IDMP requirements as well as Data Governance modules.
• Report on activities to ensure IDMP readiness until future RIMS is in place.

The Cognizant community:

• We are a high calibre team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
• Cognizant is a global community with more than 345,000 associates around the world.
• We don't just dream of a better way - we make it happen.
• We take care of our people, clients, company, communities, and climate by doing what's right.
• We foster an innovative environment where you can build the career path that's right for you.

About us:

Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, helping organizations modernize technology, reimagine processes, and transform experiences so they stay ahead in a fast-changing world.

Our commitment to diversity and inclusion:

Cognizant is an equal-opportunity employer that embraces diversity, champions equity, and values inclusion. We are dedicated to nurturing a community where everyone feels heard, accepted, and welcome. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status, or any other protected characteristic as outlined by federal, state, or local laws.

Please apply online

The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.

• Cognizant is a global community with more than 345,000 associates around the world.
• We don't just dream of a better way - we make it happen.
• We take care of our people, clients, company, communities and climate by doing what's right.
• We foster an innovative environment where you can build the career path that's right for you.

About us:
Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, helping organizations modernize technology, reimagine processes and transform experiences so they stay ahead in a fast-changing world.

Our commitment to diversity and inclusion:
Cognizant is an equal opportunity employer that embraces diversity, champions equity and values inclusion. We are dedicated to nurturing a community where everyone feels heard, accepted and welcome. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other protected characteristic as outlined by federal, state or local laws.

Disclaimer:
Compensation 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.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.