Job Description Summary

Is responsible for executing label design and reviewing related tasks in alignment with label strategy defined by the Label Lead and the established processes. This role ensures timely and accurate documentation, and status reporting to support the successful delivery of labeling activities within clinical trials

 

Job Description

• Is responsible for generation of label for IMP, randomization list/randomization schedules and ensures agreed milestones, quality are met.
• Design labels based on strategic inputs and specific study requirements. Acknowledge and manage ticket assignments promptly to ensure workflow continuity. Upload study-related forms, SLTs (Study Label Templates), and other relevant documentation in relevant repositories accurately. Provide regular updates to the Label Lead regarding task progress and issues. Maintain consistent status reporting to the Label Lead to ensure transparency and alignment.
• 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.
• Maintains Phrase Library (validated repository of country specific HA requirement and translations of phrases in country specific languages).
• If required and certified, then performs and documents GMP line unit checks (LU1b) of label(s) as defined in SOP. Notifies Team Head or Deputy about quality events/deviations or any non-Right First Time (RFT) cases.
• 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.
• Is able to describe the fundamental process and answer questions regarding label process during internal/external inspections.
• Actively participates in projects, networks and/or forums. Fulfill all related tasks and responsibilities related to own discipline.
• Ensures execution according to quality, quantity and timelines of all assigned activities.
• 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.

 

Skills Desired

Clinical Research, Clinical Trials, Lifesciences (Inactive), Partner Relationship Management (PRM), Project Planning, Waterfall Model