NOVARTIS Hiring Associate Clinical Label Manager practical experience in chemical / Pharmaceutical industry Apply Now
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
1. 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. Maintains Phrase Library (validated repository of country specific
HA requirement and translations of phrases in country specific languages).
3. Manages business administration activities of Clinicopia
(Label design application) system and Ran-domization Reporting Tool (RRT). 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.
4. 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. Is responsible for communicating challenges to internal and
external stakeholders and bring solutions to mitigate any risk(s).
5. Manages all applicable finance activities, including
grants, purchase orders (PO) and invoice approval for IMP labels, as
applicable.
6. Is able to describe the fundamental process and answer
question regarding label process during internal/external inspections.
7. Actively participates in projects, networks and/or forums.
Fulfill all related tasks and responsibilities related to own discipline.
Ensures execution according to quality, quantity and timelines of all assigned
activities.
8. 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
Minimum requirements
WHAT YOU’LL BRING TO THE ROLE:
1. > 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
2. Basic knowledge of drug development and clinical supply
process.
3. Basic project management, good organization and planning
skills
4. Good knowledge of HSE/GMP standards and processes
5. Problem-solving and idea generation skills
6. Good presentation skills and fundamental leadership
skills.
7. Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.
TO APPLY CLICK HERE
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