Associate
Clinical Label Manager @ Novartis
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
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
Degree in science, engineering or equivalent. Good English ,Fluent
in local language
1. > 3 years of practical experience in chemical / pharmaceutical
industry or > 2years of experience in field of expertise
2. Apprenticeship or formal education in a logistical, technical
or related business area 3. Basic knowledge of drug development and clinical
supply process.
4. Basic project management, good organization and planning skills
5. Good knowledge of HSE/GMP standards and processes
6. Problem-solving and idea generation skills
7. Good presentation skills
8. Fundamental Leadership skills.
9. Good communication, negotiation and interpersonal skills. Ability
to work in interdisciplinary teams.
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