Associate Clinical Label Manager
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.
Your responsibilities include, but are not limited to:
• Is responsible for generation/coordination of labels 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, pack material, analytical 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 nominated.
• 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 Managers 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 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 teams representative of the patients and communities we serve.
• 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
766 million lives were touched by Novartis medicines in 2021, 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!
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
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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