Novartis Healthcare Pvt. Ltd.

Associate Clinical Label Manager

Job Location:  Hyderabad
Job Description:  SkillSet: supply chain, reporting tool, purchase orders, drug development, service providers.
1. Is responsible for generation of label for IMP, medication list/randomization list/randomization schedules and ensures agreed milestones, quality and costs are met.
2. Is accountable for label compliance with respect to study design, pack design, analytical specifications of the IMP along with country specific Health Authority (HA) requirements and Novartis standards of compliance.
3. Maintains Phrase Library (validated repository of country specific HA requirement and translations of phrases in country specific languages).
4. Manages business administration activities of Clinicopia (Label design application) system and Randomization Reporting Tool (RRT).
5. If required and certified then performs and documents GMP line unit checks of label(s) as defined in SOP. Notifies Team Head or Deputy about quality events/deviations or any non-Right First Time (RFT) cases.
6. Keeps clear alignment with all the internal (e.g. Clinical Trial Supply Managers, Supply Chain Managers etc.) and external (e.g. external label service providers for specialized labels) stakeholders for IMP label related activities.
7. Is responsible for communicating challenges to internal and external stakeholders and bring solutions to mitigate any risk(s).
8. Manages all applicable finance activities, including grants, purchase orders (PO) and invoice approval for IMP labels, as applicable.
9. Is able to describe the fundamental process and answer question regarding label process during internal/external inspections.
10. Actively participates in projects, networks and/or forums. Fulfill all related tasks and responsibilities related to own discipline.
11. Ensures execution according to quality, quantity and timelines of all assigned activities.
12. Adheres to and utilizes existing processes and procedures to achieve agreed outcomes in a consistent and disciplined way. Completely adheres to Novartis values and behaviors. For generic activities refer to the role profile
Minimum requirements What you ll bring to the role:
Degree in science, engineering or equivalent. Good English ,Fluent in local language
1. 3 years of practical experience in chemical / pharmaceutical industry or 2years of experience in field of expertise
2. Apprenticeship or formal education in a logistical, technical or related business area
3. Basic knowledge of drug development and clinical supply process.
4. Basic project management, good organization and planning skills
5. Good knowledge of HSE/GMP standards and processes
6. Problem-solving and idea generation skills
7. Good presentation skills
8. Fundamental Leadership skills.
9. Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.
Functional Area:  Supply Chain / Logistics
Experience:  3 - 5 years
Qualification:  ("Graduation in any field")
Salary:  4.0 Lakh to 7 Lakh INR
Novartis Healthcare Pvt. Ltd.
Job Ad publication date: 19 Apr 2021