IQVIA Released Job Openings On 21/03/2022.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.
IQVIA Recruiting Candidates 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 : Bangalore
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application:21/03/2022
- 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: Sun Pharma Walk In Interview On 23rd March 2022
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.