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Clinical Label Manager
Novartis
posted 2mon ago
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Flexible timing
Key skills for the job
Job Description
Summary
Contribute and execute labelling activities 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. Has operational end-to-end responsibility for assigned supply activity (label related).
About the Role
Role 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
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 SMEs / 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.
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 SMEs / 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.
Role 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
Employment Type: Full Time, Permanent
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Anonymous · Legal & Regulatory
in Bangalore / Bengaluru
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The 12 days WFO facility is good.
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The worst part within Novartis is the "Role Impact". Once your role is impacted, the company will kick you out without any redeployement opportunity.
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Flexible timing
Monday to Friday
No travel
Day Shift
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