393652BR
Mar 06, 2024
India
About the Role
Your responsibilities will 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 IRT 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.
• Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
• Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall GCS external cost (e.g. labels, packaging, distribution and comparators).
• Actively contributes to the GCS subteam as a full member. Ensures adequate, proactive exchange of relevant knowledge & information between the GCS sub team and the CTT. Fully supports, prepares the GCS PL to adequately address GCS-considerations at various cross-functional teams e.g. TRD sub team, ICT, etc.
• 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 IRT 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.
• Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
• Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall GCS external cost (e.g. labels, packaging, distribution and comparators).
• Actively contributes to the GCS subteam as a full member. Ensures adequate, proactive exchange of relevant knowledge & information between the GCS sub team and the CTT. Fully supports, prepares the GCS PL to adequately address GCS-considerations at various cross-functional teams e.g. TRD sub team, ICT, etc.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• 2 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
• Apprenticeship or formal education in a logistical, technical or related business area
• 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
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Apprenticeship or formal education in a logistical, technical or related business area
• 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
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Development
TECHNICAL R & D GDD
India
Hyderabad, AP
Nov Hltcr Shared Services Ind
Research & Development
Full Time
Regular
No
