location_onIndia,
watch_later Posted: Jul 18, 2024
Skills Required
Nice To Have skills
Job Description
About the job
Job Description
Your responsibilities include, but are not limited to:
• Represents GCS as a core member in the integrated Clinical Trial Team (iCTT); defines and advises the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management.
• Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
• Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems.
• Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.
• Defines clinical supply parameters for NIRT set up and initiates subsequent updates throughout the duration of the clinical trial
• Develops and executes a trial-level project plan together with all other relevant roles. Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
• Collaborates with all relevant line function partners for country submission and approval timelines (including IND-IMPD amendment) to develop optimal supply strategy.
• Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots.
Commitment to Diversity Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
• 5 years of practical experience in chemical / pharmaceutical industry or 3 years of experience in field of expertise
• Good expertise in related field. Good knowledge about the Drug Development process
• Basic project management, good organization and planning skills
• Knowledge of relevant regulations (e.g., GMP, HSE etc.) and Novartis specific standards.
• Demonstrates problem-solving and idea generation skills
• Good presentation skills; Fundamental Leadership skills.
• Very good communication, negotiation, and interpersonal skills. Ability to work in interdisciplinary teams.
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