346757BR
Jun 07, 2022
India

Job Description

2025! This is the year that Global Clinical supply is targeting for completing the evolution our systems into a “digital enabled” landscape of 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 (TRD) teams and the Clinical teams! At GCS, we aspire to become a data and digital powered, resourceful , agile organization to deliver more products to more patients efficiently, through empowered and highly capable teams. The Information Governance Manager (IGM) will coordinate the setup, maintenance and development of the Global Clinical Supply (GCS) Information management framework, to ensure appropriate behavior in the valuation, creation, storage, use, archiving and deletion of information. They will contribute to establishment of the Supply Chain Master Data Analytics framework and relative IT solutions, integrated with the other functions of the TRD organization. This role is accountable for enforcement and maintenance of the agreed process once established.

Your responsibilities include, but are not limited to:



• Is responsible for generation/coordination of labels for IMP, medication list/randomization list/random-ization schedules and ensures agreed milestones, quality and costs are met. Is accountable for label compliance with respect to study design, pack design, pack material, analyt-ical specifications of the IMP along with country specific Regulatory Authority (RA) requirements and Novartis standards of compliance.

• Maintains Phrase Library (validated repository of country specific HA regulatory requirement and translations of phrases in country specific languages), if nomintated.

• If nominated manages business administration activities of Labelling system and Randomization Re-porting Tool (RRT) and participate in system enhancement initiatives as appropriate.If required and qualified performs and documents GMP line unit checks of label(s) as defined in SOP. When required leads investigations if certified in case of quality events/deviations or any non-Right First Time (RFT) cases and notifies the Team Head or Deputy.

• 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. Act as subject matter expert on label process during internal/external inspections as required.

• Is responsible for communicating challenges to internal and external stakeholders and bring solutions to mitigate any risk(s). Support the Business owner by coordinating the vendor management and vendor performance when required . 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. Support SME's / SPOC / SU / BPM (Business Process Manager) to define processes, identify and support initiatives for process improvement and simplification when required

• Actively participates in projects, networks and/or forums. Fulfill all related tasks and responsibilities related to own discipline. Be a mentor for the new CLM associates. Ensures colleagues know and use the appropriate processes and procedures and are aware of the risks of non-compliance as re-quired

• 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 con-sistent 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 teams representative of the patients and communities we serve.

Minimum Requirements

• 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
• Fundamental Leadership skills.
• Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear 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
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346757BR

Associate Clinical Label Manager

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