NIFDC Task Force Lead
2 weeks ago
Datum: Apr 22 2024
Job Purpose:
To lead a cross-functional Task Force within GSK China to enable clinical lots (DS, DP, Adjuvant)/IMP and NDA testing requirements at NIFDC on GSK new vaccines can be completed in a timely and high-quality manner to support their registrations in the China market.
Key Responsibilities:
- Lead China LOC cross-functional teams (e.g.RA TA, RA CMC, Clinical Operations, Supply Chain, Quality etc.) and work together with global teams to enable efficient Analytical Method Transfer (from global R&D and GSC to NIFDC) on new vaccines to support their respective clinical lots/IMP (Investigational Medicinal Products) NIFDC testing and NDA testing.
- Lead China LOC cross-functional teams and work together with global teams for timely clinical lots/IMP NIFDC release to meet specific study commencement schedules by:
- Coordinate cross-functions to set up comprehensive clinical lots/IMP testing plan
- Overall track and report local activity progress, including but not limited to clinical lots/IMP and reagents importation.
- Escalate risk/issue and to develop mitigation or solutions
- Act as a key member and Subject Matter Expert (SME) in project team to provide input regarding method transfer and clinical lots/IMP testing.
- Explore development acceleration opportunities to expedite clinical lots/IMP and NDA testing timeline e.g. seek 3rd party lab to pre-test the IMP analytic method before transfer to NIFDC, optimize the project strategy and implementation process from technical perspective etc.
- Act as Point of Contact between NIFDC and GSK China LOC to enhance engagement and communications on clinical lots/IMP and NDA testing related matters.
- Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.
Qualifications:
- A minimum of 10 years’ experience in the China pharmaceutical market and at least 6 years in MNC, preferably with biological product/vaccines handling experience.
- Proven ability to communicate (written/oral) with various functions and with Chinese Authority.
- Fluency in English
- Ability of cross functional co-operation. Strong ownership and cross boundary working mindset
- A strong capability in problem solving
- Strong negotiation skills
- Ability to coordinate, influence and lead people or a virtual team
- Ability to work under time pressure and deliver project milestone in a timely manner.
Unser Ziel ist es, eines der innovativsten, leistungsfähigsten und vertrauenswürdigsten Gesundheitsunternehmen der Welt zu werden. Wir sind davon überzeugt, dass jeder von uns einen einzigartigen Beitrag zu GSK leistet. Wenn wir unser Wissen, unsere Erfahrungen und besonderen Talente vereinen, werden wir ein unglaubliches Ergebnis erzielen. Kommen Sie zu GSK und finden Sie einen inspirierenden Arbeitsplatz, an dem Sie Ihr Bestes für unsere Patienten und Verbraucher geben. Ein Ort, an dem Sie ganz Sie selbst sein, sich wohlfühlen und weiterentwickeln können.
Wichtiger Hinweis für Arbeitsvermittlungsunternehmen/‑agenturen
GSK akzeptiert keine Empfehlungen von Arbeitsvermittlungsunternehmen und/oder Arbeitsvermittlungsagenturen für die auf dieser Website ausgeschriebenen freien Stellen. Alle Arbeitsvermittlungsunternehmen/‑agenturen müssen sich an die Abteilung für gewerbliche und allgemeine Beschaffung/Personalabteilung von GSK wenden, um die schriftliche Einwilligung einzuholen, bevor sie GSK Bewerber empfehlen. Der Erhalt einer schriftlichen Einwilligung ist Voraussetzung für jegliche Vereinbarung (sowohl mündlich als auch schriftlich) zwischen dem Arbeitsvermittlungsunternehmen/der Arbeitsvermittlungsagentur und GSK. Falls diese Genehmigung nicht erteilt wurde, wird davon ausgegangen, dass sämtliche Handlungen des Arbeitsvermittlungsunternehmens/der Arbeitsvermittlungsagentur ohne die Zustimmung von GSK oder ohne eine vertragliche Vereinbarung mit GSK unternommen wurden. Aus diesem Grund haftet GSK nicht für irgendwelche Gebühren, die aus solchen Handlungen oder aus Empfehlungen von Arbeitsvermittlungsunternehmen/‑agenturen für die auf dieser Website ausgeschriebenen freien Stellen entstehen.
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