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Post: Associate GL Manager (AGLM)
Job Description:
The Associate GL Manager (AGLM) is responsible for the global labelling of assigned Novartis Pharma products across all BUs and BFs to provide high quality information to prescribers and patients whilst minimizing product liability risks. The AGLM is responsible is responsible for PSUR, CDS, BSS, BPL, IPL preparation and support to the GL planning and monitoring of the worldwide implementation of corporate agreed product information changes (Core Data Sheet (CDS) updates and amendments) for Novartis Pharma products in order to achieve international harmonization of Pharmaceutical Product Information.
1.Global Product Information: Create and maintain regulatory compliant, competitive and up to date global labelling documents (Core Data Sheet (CDS), Basic Patient Leaflet (BPL), Basic Succinct Statement (BSS)) for assigned products
2.CDS Supporting Documents: Organise and lead the creation of high quality documents sup-porting changes to the CDS with internal and/or external experts
3.Global Labelling Committee (GLC): Present proposed changes in global product information documents to the Global Labelling Committee (GLC) for review and approval
4.Expert Labelling Task Forces: Organise and lead cross functional expert labelling task forces to reach consensus on global labelling matters and prepare supporting documents for CDS changes. Lead the PSB/ GLC follow-up activities related to global labelling
5.Interactions with local DRA worldwide: Interact with DRA CPOs and DRA-EM to ensure timely implementation of global labelling changes in local product information, and ensure international consistency and compliance with the CDS. Guide and support DRA CPOs and DRA-EM for all labelling related HA negotiations
6.Periodic Safety Update Report (PSUR): Provide global regulatory contribution to PSURs for assigned products, and follow up on potential Core Data Sheet changes considered in PSURs
7.CDS query management: Lead cross functional Teams in responding to HAs for CDS queries
8.International Package Leaflet (IPL): Prepare, update/amend International Package Leaflets for all Pharma products in compliance with the Core Data Sheet(includes the coordination of translations, Artworks requests, proof-reading of Artwork, and distribution of leaflets to CPOs)
9.Basic Patient Leaflet (BPL), Basic Succinct statement (BSS): Maintain regulatory com-pliant, competitive and up to date BPL and BSS based on the Core Data Sheet for selected global Novartis Pharma products
10. Review the work done by GL specialist /associate.
11.Process Improvements: Review and adapt Novartis processes to changing requirements in Global Labelling.
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Candidate Profile: Masters in Life Sciences or Pharmacy/ Medicine. PhD in Life Sciences or Pharmacy preferred. English Overall 4 -7 years (preferably 1 -2 years in Global labelling) relevant experience in regulatory/ clinical/ medical functions with
• Sound understanding of medical and scientific terminologies
• Good understanding of drug safety information
• Project management and communication skills
• Ability to lead cross-functional teams in matrix environment
Additional Information:
Experience: 4-7 Years
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 132365BR
End Date: 25th Dec., 2013
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