IQVIA Released Job Openings On 11/04/2022.The Company offers commercial, physical, and biological research and development services, as well as value-based analyses, research studies, clinical management analytics, and health outcome optimization services.Application form link provided at the end of post. Eligibility for the Regulatory Affairs Global Labeling Lead as follows.
Vacancy Details:
IQVIA Recruiting BSc or equivalent in a scientific or related field (Required) Nursing with 01+ Years Experience for Regulatory Affairs Global Labeling Lead Position.Complete Details for the Regulatory Affairs Global Labeling Lead as follows.
Important Details :
- Location : Bengaluru
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application:11/04/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Related Job: Piramal Looking For FRESHERS
Job Description/Skills Required
- Completes all labelling deliverables within the required timelines (including those relating to PSMF).
- Investigates specified APIs proposed for CCDS creation/revision/withdrawal
- Leads the CCDS creation/revision process and co-ordinates the CCDSworking team (CCDS-WT).
- Leads the USPI (United States Prescribing Information) revision process and co-ordinates the Labeling Working Group (LWG)
- Assesses labelling issues, including alignment with CCDS and alignment to FDA Labeling guidance
- Endorses Prescribing Information and Patient Information content prior to final approval.
- Organises a back-up for planned absences.
- Keeps the IQVIA API/ Product Listing up-to-date for the products for which he/she is the GLL.
- Operates to QMS documents and non-QMS documents for the regulatory services provided.
- Proposes improvements to the current client QMS procedures to the EPIC RA Labeling Lead.
- Conducts quality control (QC) review for deliverables prepared by other GLLs.
- Raises suspected quality issues and process deviations with the EPIC RA Labeling Lead.
- Escalates LOCs non-adherence to the Local exception forms, deferral request form and RIM System ‘PRISM Data Entry Form (PDEF)’s in accordance with the timelines and/or to submission timeline according to the agreed Escalation Plan for LOCs.
- Enters own labeling-related tasks in the IQVIA internal Project Management tool.
- Reviews all open deliverables on a weekly basis and updates as applicable
- Updates the deliverables information and moves status to “Complete” when the deliverable is complete.
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