- 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.
- 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.
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NIFDC Task Force Lead - Beijing, 中国 - GSK
描述
Site Name: China - Beijing - ChaoYang District - Ocean International Centre - Tower APosted Date: Apr
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:
Qualifications:
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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