Analyst Clinical Label Management at Novartis

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

19 Jun, 26

Salary

0.0

Posted On

21 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Label Design, Documentation, Status Reporting, IMP Labeling, Randomization Lists, Ticket Management, Compliance, Health Authority Requirements, Phrase Library Maintenance, GMP Line Unit Checks, Stakeholder Communication, Project Participation, Quality Assurance, Process Adherence, Problem Solving, Presentation Skills

Industry

Pharmaceutical Manufacturing

Description

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. Education (minimum/ desirable) Degree in science, engineering or equivalent. Work Experience: 1. > 2 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise 2. Apprenticeship or formal education in a logistical, technical or related business area 3. Basic project management, good organization and planning skills 4. Good knowledge of HSE/GMP standards and processes 5. Problem-solving and idea generation skills 6. Good presentation skills 7. Fundamental Leadership skills. 8. Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams Skills Desired gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

This role executes label design and reviews related tasks according to the label strategy, ensuring timely and accurate documentation and status reporting for clinical trial labeling activities. Responsibilities include generating labels for IMP and randomization lists, maintaining compliance with study design and regulatory requirements, and managing documentation repositories.