Global Labelling Transformation Supply Manager - Geneve, Schweiz - Novartis

Novartis

Geprüftes Unternehmen

Geneve, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

AAA Statement

Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine.

AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Job Purpose:
The Labeling Transformation Supply Manager autonomously coordinates the endtoend supply activity to transition all regulated packaging components, according to the project requirements (e.g. Geneva II). He/She is responsible for the information management flow of the artwork associated to packaging deliverables, ensuring that compliant artworks are issued and in line with approved labelling documentation, for digital mock up and / or printed material. He/She is responsible to provide deliverables in accordance with the planned milestones.
Assess and drives supply planning activities strictly interconnected with labeling coordination at regulatory level, and in accordance to the country presentation, guaranteeing alignment with local regulatory representatives.
Designs realistic commitments optimizing and readjusting the plan based to the crossfunctional teams' expectations, by structuring roll out activities with Artwork Operations, for 1st launches and lifecycle labelling, in relation to transformation projects. Collaborate closely with the regulatory affairs team, being an SPoC for the transformation of supply labeling and acting as a key planning function, in line with country implementation strategies, approved and defined by key project members.
Acts as SPoC for implementation at each site, supporting crossfunctional teams in reviewing / releasing related Supply Artwork documentation.
Actively monitor and supervise artwork trackers and documents for the marketed portfolio, products under development (clinical supply labelling for clinical trials sponsored by NVS/AAA or by investigators(IMPD / IND) and IIT), medical supplies, as needed, involved in transition projects in the NVS/AAA context.
Interact also with project related subteams, IT department, manufacturing sites, supply chain / logistics, PMO (Project Management Office) to ensure compliance with regulatory compliance regarding artwork and related documentation.
In addition to management activities, the Labeling Transformation Supply Manager supports the transition of specific operational tasks, playing a supporting role in linking the specificities of Radioligand Therapy Artworks towards the Novartis operating model.
Major Activities:
Lead, plan and coordinate independently the end to end Supply process of an Artwork Change Requests in relation to integration projects and bridges Supply Chain feasibilities, with local country needs, with Internal stakeholders and External partners;
Participates to multiple Project team and RA Subteam meetings to align requests with priorities;
Acts as SPoC, in relation to labelling changes planned for submissions and releases in scope of the portfolio transition;
Constantly cross refer and align with business requirements documentation issued by Global Artwork Standards Process excellence Manager;
Coordinate and contribute in defining labelling processes in line with newly designed Operational models;
Supervise the update and tracking activities of internal documentation for any artwork item impacted by business transition artwork projects;
Closely collaborate with Regulatory, Labelling, crossfunctional project teams, manufacturing sites and external partners to ensure full regulatory compliance with regards to approved artwork for marketed products as well as any other pertinent field.
Lead the updates impacting documentation for any type design request impacting specific items in scope of transition projects.

Excellence and compliance- Full control and confidence over RLT supply model, labelling, artwork and printing related process and documentation;

Contribute to enforce strategic harmonization in relation to management of Artwork Operational activities;
Oversee and integrate complexities in perfect alignement with RA and Artwork Supply infrastructure towards markets and sites

Key Performance Indicators:

1. Full ownership and traceability with regards to implementation of labelling requirements in line with supply needs according to each transformation project in scope of the integration,
2. Full control over implementation of approved versions of the label as well as confidence over artwork related documentation;
3. Revise labelling and artwork do