Similar posts
TRD China Project Manager
- Regulatory Affairs
- Permanent
This vacancy has now expired. Please see similar roles below...
Proclinical has a brilliant opportunity for a TRD China Project Manager to be based in Boston, MA. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. The TRD China RA Project Manager will organize and track China Regulatory Affairs work to ensure efficient execution. This includes oversight of workstream execution deliverables to ensure milestones are being met; and the creation and updating of team metrics and scorecards. The work of the workstream is to deliver the needed China file conversion from paper or systems internally, into US systems, across all businesses. Files that are in paper will need to be collected and verified as 'accurate'. This work will be across 10 organizations; starting with 20 files and touching all 306 over the next 12 months or so. This position will partner with the TRD China Project Lead to insure workstream success.
Job Responsibilities:
- Organize and track China RA work to ensure efficient execution
- Create and maintain workstream metrics and dashboards
- Work collaboratively with both the technical team in the US + the China Team to ensure clarity of requirements, evidence availability, timing, and execution tracking
- Ensures personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health Care Compliance.
- Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance always.
- Performs other related duties as required.
Skills and Requirements:
- A minimum of a Bachelor's Degree or equivalent.
- A minimum 8 years of experience in a regulated industry.
- Project Management experience required; PMP certification preferred.
- Travel approximately 20% domestic/international may be required
- Strong knowledge of global regulatory requirements and how China regulations are satisfied - is preferred
- Ability to communicate at all levels of the cross-functional organization; breakdown complex, multi-faceted issues and drive results; work in multi-cultural environment.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Related jobs
Highly Competitive
London, England
Proclinical is seeking a skilled CMC Writer to join our client's team, focusing on regulatory affairs within the oncology and biotechnology sectors.
Highly Competitive
Slough, England
Help bring science to life and join a leading pharmaceutical company where you can play a key role within Regulatory Affairs and assist in driving healthcare innovation!
Highly Competitive
Boston, USA
Proclinical is partnering with a leading biotech company to recruit an experienced CMC Writer for a fully remote, 6-month contract opportunity.
Highly Competitive
Windsor and Maidenhead, England
Are you ready to embrace the flexibility of remote work and drive innovation, collaboration, and growth-no matter where you are?
US$245000 - US$265000 per annum
Boston, USA
Looking to escape your long commute to work? Unlock your next remote working position with this exciting role in Regulatory Affairs!
Highly Competitive
Berlin, Germany
Senior Regulatory Affairs Manager (m/w/d) - Permanent - Berlin.