Labelling Specialist-I

Job description

Job Description

The Labeling Specialist is responsible for the ‘Universal Presentation' related art- work activities of DRA-Global labelling (GL) for all Novartis Pharma products. The main activities are preparation of ‘Universal Artwork Presentation' in coordination with Country Pharma Organisa- tion (CPO), IPL authors and other stakeholders, and review and approval of the artworks (for text change requests for non-safety label changes), for worldwide implementation of corporate agreed changes to product information for international Novartis Pharma products in order to achieve international harmonization of Pharmaceutical Product Information. This position will also provide support for the required operational activities related to Global Labelling.
1. Initiating and coordinating text change and mock-up requests for all non-safety label changes of universal presentation artworks in the ‘Artwork Change Request Workflow Tool' based on the CPOs' requirements for Asia Pacific, Middle East, African Cluster; Latin America and Cana- da [AMAC LatCan] countries. Initiation of Text change requests for safety label changes as per the information provided in IPL plan. 2. Review & approval of the Universal Artworks changes Printed Packaging Material Sheet (PPMS) 3. After International Package Leaflet (IPL) dispatch (both safety and non-safety label changes)– Initiation of artwork change request in the ‘Artwork Change Request Workflow Tool', coordina- tion for translations, proofreading of Artwork, and distribution of translated leaflets to CPOs, performance of Post-Distribution Changes (PDCs) in the regulatory compliance database sys- tem and approval of PPMS for all IPL changes. 4. Collaboration with the GL Managers to provide support for Global Labelling operational activi- ties: a. Preparation of registration status reports for the DRA input to Periodic Safety Reports (PSURs), CDS updates etc. from the regulatory compliance database system b. Performing PDCs in the regulatory compliance database system c. CDS update/amendment and dispatch related activities d. Maintenance of various GL databases like the repository database systems, the regu- latory compliance database, SharePoint etc, 5. Post Distribution Changes (PDCs) : To perform Post Distribution Changes to Core Data Sheet(CDS) and Periodic Safety Update Report (PSURs) in DRAGON within five calendar days from the date of dispatch of CDS/PSUR for all GL products. 6. PDC query Management: To address the queries related to PDCs for CDS/PSUR from CPOs on Baseline Folders and Countries of dispatch.

Desired profile

Bachelor degree in Pharmacy/Life-Science (e.g. Pharmacy, Biotechnology, Pharmacology, Quality Assurance) or DIPLOMA in Science with relevant experience. Preferred – Masters in Pharmacy/Life-Science English • 1 - 4 years of relevant experience (Regulatory, Labelling, Clinical or Quality Assurance) • 1 – 2 years knowledge of global regulatory and/or Medi- cal & CMC documentation preparation experience for writing CTD module 4 & 5, Product Labelling, CTA/IMPDs, ANDAs, MAAs, INDs, BLAs and NDAs would be of advantage. • Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable. • Ability to work successfully with extended, global project teams and coordinate activities simultaneously on mul- tiple projects under pressure of time and workload. • Effective planning, organizational, and interpersonal skills. • Computer literacy.



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