| || 226872BR |
| || Associate Manager I- Clinical Label Management |
| || NBS |
| || GLOBAL REGULATORY AFFAIRS AL |
| || India |
| || Hyderabad |
| || India Novartis Healthcare Private Limited |
| || Research & Development |
| || Full Time |
| || Regular |
| || You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV. |
| || Role Purpose:
Is responsible for the creation and content of labels for Investigational Medicinal Product (IMP) according to all internal and external requirements and regulations and in line with timelines of the overall project (study).
Individual Activities (main activities, accountabilities)
1. Generates label for Investigational Medicinal Product and ensures agreed milestones, quality and cost are met.
2. Is accountable for label compliance with study specific, country specific and QA requirements as well as with Novartis Standards of Compliance.
3. Is responsible for creation of randomization list/ schedules.
4. Manages business administration activities of Clinicopia/RRT in SAP.
5. Maintains Phrase Library.
6. Ensures alignment with all related clinical trial activities (Trial Mgt. and DRA) to achieve desired customer (Development Franchise) timelines.
7. Performs and documents GMP confirm line unit check of labels as defined in SOP.
8. Informs Team Head or deputy about quality event i.e. deviation.
9. Be responsible for communicating issues to the internal and external stakeholders and negotiate to bring solutions.
10. Is able to describe the process and answer question regarding label process during internal/external inspections.
11. Manages all applicable finance activities, including Grants, Purchase Orders (PO) and invoice approval.
| || sound clinical knowledge and experience in QA, Regulatory Affairs, Artwork, Labelling.
Exp: Min 2+ yrs of experience.