Associate Clinical Label Manager

323020BR
Sep 17, 2021
India

Job Description

300+ associates. Join a team of globally collaborative colleagues at the ‘Global Clinical Supply (GCS)’ function to support clinical trials from Phase 1 to approval and be a key interface between Technical Research & Development teams and the Clinical teams!
At ‘Global Clinical Supply (GCS)' we aspire to become an intelligent, agile organization to deliver more products to more patients more efficiently, through empowered and highly capable GCS teams. As Associate Clinical Label Manager you would drive and execute label strategy for clinical trial supplies (IMP) to ensure fulfillment of supply chain resulting in no stock outs /missed milestones and/or supply interruptions impacting patients due to label quality or availability.”

YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• Responsible for generation of label for IMP, medication list/randomization list/randomization schedules and ensures agreed milestones, quality and costs are met.
• 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).
• Manages business administration activities of Clinicopia (Label design application) system and Randomization Reporting Tool (RRT). 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.
• Keeps clear alignment with all the internal (e.g. Clinical Trial Supply Managers, Supply Chain Man-agers etc.) and external (e.g. external label service providers for specialized labels) stakeholders for IMP label related activities. Is responsible for communicating challenges to internal and external stakeholders and bring solutions to mitigate any risk(s).
• Manages all applicable finance activities, including grants, purchase orders (PO) and invoice approval for IMP labels, as applicable.
• Is able to describe the fundamental process and answer question 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.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

WHAT YOU’LL BRING TO THE ROLE:

• > 3 years of practical experience in chemical / pharmaceutical industry or > 2years of experience in field of expertise. Apprenticeship or formal education in a logistical, technical or related business area
• Basic knowledge of drug development and clinical supply process.
• 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 and fundamental leadership skills.
• Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
TECHNICAL R & D GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
careers default image
323020BR

Associate Clinical Label Manager

Apply to Job Access Job Account