Novartis Careers: Clinical Analyst Role | Chemical Science Graduates Apply Now
Are you looking for a Clinical Analyst role through Novartis Careers in India? This Analyst Clinical Label Management position in Hyderabad is an excellent opportunity for professionals seeking Chemical Science Jobs in the pharmaceutical industry. The role focuses on clinical trial labeling, compliance, and quality execution within a global healthcare organization.
About Novartis
Novartis is a global healthcare leader committed to reimagining medicine to improve and extend lives. Through Novartis Careers, professionals can explore rewarding roles such as Clinical Analyst positions and other Chemical Science Jobs across clinical development, technical operations, and pharmaceutical innovation.
- Job Title: Analyst, Clinical Label Management
- Job ID: REQ-10070942
- Location: India
- Education: Degree in science, engineering, or equivalent.
Summary
Is responsible for executing label design and reviewing related tasks in alignment with the 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.
About the Role
- Is responsible for the generation of labels for IMP, randomization list/randomization schedules, and ensures that agreed milestones and 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 requirements 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 the label process during internal/external inspections.
- Actively participates in projects, networks, and/or forums. Fulfill all related tasks and responsibilities related toone’s 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.
Work Experience
- > 2 years of practical experience in the chemical/pharmaceutical industry or > 3 years of experience in the field of expertise
- Apprenticeship or formal education in a logistical, technical, or related business area
- Basic project management, good organization, and planning skills
- Good knowledge of HSE/GMP standards and processes
- Problem-solving and idea generation skills
- Good presentation skills
- Fundamental Leadership Skills.
- Good communication, negotiation, and interpersonal skills. Ability to work in interdisciplinary teams
