Associate Clinical Label Manager Job Opening @ Novartis
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Job Id: 281038BR
Job Title: Associate Clinical Label Manager
Job Description
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. Execute and monitor timely activities related to assigned supply activity under the guidance of senior associates
Eligibility:
- > 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 6. 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:
1. Is responsible for generation of label for IMP, medication list/randomization list/randomization schedules and
ensures agreed milestones, quality and costs are met.2. 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.
3. Maintains Phrase Library (validated repository of country specific HA requirement and translations of phrases in country specific languages).
4. Manages business administration activities of Clinicopia (Label design application) system and Randomization Reporting Tool (RRT).
5. 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.
6. 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.
7. Is responsible for communicating challenges to internal and external stakeholders and bring solutions to mitigate any risk(s).
8. Manages all applicable finance activities, including grants, purchase orders (PO) and invoice approval for IMP labels, as applicable.
9. Is able to describe the fundamental process and answer question regarding label process during internal/external inspections.
10. Actively participates in projects, networks and/or forums. Fulfill all related tasks and responsibilities related to own discipline.
11. Ensures execution according to quality, quantity and timelines of all assigned activities.
12. 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. For generic activities refer to the role profile
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