When you join Cognizant, you not only touch the future, but you craft the next generation of healthcare. We are an organization that is regularly rated highly as the place to work by our employees as well as alumni. We offer flexible workforce benefits supporting a work/life balance. Apply today and start making a difference in your career.
Cognizant is a leader in pharmacovigilance (PV) services, with best-in-class processes and expert PV resources; trailblazing AI, automation and cloud-infused PV technologies; and an end-to-end partner ecosystem.
We have a new opportunity on our team for a Senior Regulatory Systems & Strategy Manager to work closely with the Regulatory Systems & Strategy (RS&S) Associate Director to ensure xEVMPD and IDMP/SPOR related submissions according to evolving regulatory requirements.
As the Senior Regulatory System and Strategy Manager, your day will not be boring. An example your responsibilities include
- Support IDMP/SPOR data readiness for the pharmaceuticals in the EU/EEA 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.
The successful incumbent’s performance is measured by
- 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.
To be a successful contender for this exciting opportunity, you need to bring
- BS in a life science or related program or an MBA in Project Management
- Be fluent in English. Other language fluency would be a great asset
- 7 years’ experience in the pharmaceutical industry, mainly in a regulatory capacity and closely related areas such as clinical development, GxP, Regulatory CMC, QA, Project Management, etc.
- Familiar with global Health Authority regulations/guidelines and IDMP specific (e.g., EU IG, FDA regulations, ICH and EMA guidelines/directives.
Here at Cognizant, your talent and hard work do not go unnoticed. We offer amazing benefits including rich insurance programs to choose from, amazing PTO and paid holidays every year, 401k contribution matches, opportunities to learn and grow your talents and your career path, and so much more. All of this in addition to a competitive pay structure!
Salary And Other Compensation:
Applications will be accepted until 10/11/2024
The annual salary for this position is between $125,000 – $150,000 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.
An inclusive environment embracing diversity: for the second time, Cognizant has been named to the Forbes list of Best Employers for Diversity based on survey responses from its employees!
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without requiring company sponsorship now or at any time in the future.
When you join Cognizant, you not only touch the future, but you craft the next generation of healthcare. We are an organization that is regularly rated highly as the place to work by our employees as well as alumni. We offer flexible workforce benefits supporting a work/life balance. Apply today and start making a difference in your career.
Cognizant is a leader in pharmacovigilance (PV) services, with best-in-class processes and expert PV resources; trailblazing AI, automation and cloud-infused PV technologies; and an end-to-end partner ecosystem.
We have a new opportunity on our team for a Senior Regulatory Systems & Strategy Manager to work closely with the Regulatory Systems & Strategy (RS&S) Associate Director to ensure xEVMPD and IDMP/SPOR related submissions according to evolving regulatory requirements.
As the Senior Regulatory System and Strategy Manager, your day will not be boring. An example your responsibilities include
- Support IDMP/SPOR data readiness for the pharmaceuticals in the EU/EEA 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.
The successful incumbent’s performance is measured by
- 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.
To be a successful contender for this exciting opportunity, you need to bring
- BS in a life science or related program or an MBA in Project Management
- Be fluent in English. Other language fluency would be a great asset
- 7 years’ experience in the pharmaceutical industry, mainly in a regulatory capacity and closely related areas such as clinical development, GxP, Regulatory CMC, QA, Project Management, etc.
- Familiar with global Health Authority regulations/guidelines and IDMP specific (e.g., EU IG, FDA regulations, ICH and EMA guidelines/directives.
Here at Cognizant, your talent and hard work do not go unnoticed. We offer amazing benefits including rich insurance programs to choose from, amazing PTO and paid holidays every year, 401k contribution matches, opportunities to learn and grow your talents and your career path, and so much more. All of this in addition to a competitive pay structure!
Salary And Other Compensation:
Applications will be accepted until 10/11/2024
The annual salary for this position is between $125,000 – $150,000 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.
An inclusive environment embracing diversity: for the second time, Cognizant has been named to the Forbes list of Best Employers for Diversity based on survey responses from its employees!
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without requiring company sponsorship now or at any time in the future.
