Clinical Affairs Specialist

Location: 

Beijing, CN

Contract Type:  Regular Full-Time
Area:  Clinical Trials
Req Id:  466790

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

 

Clinical Affairs Specialist ensures pre-clinical studies have been achieved and prepare clinical protocols and report for a succesful submission

 

What your responsibilities will be

 

  • Analyse and discuss the matching of the product requirements and the claims requested by the Authorities
  • Analyse and discuss the results of the different pre-clinical studies
  • Analyse and discuss the results of the lot variability, sample dependencies and SW/instrument maturity 
  • Takes all the product performance, medical practioning considerations, clinical practices to create a set of inputs for the clinical study protocol
  • Have been achieved, lead presubs & regulators clinical questions, owns clinical protocols and report, oversees the Data management plan, internal liase with PD, R&D, QA, MRA.
  • Discuss and argue with tha Authorities during the NB/FDA(/NMPA/etc meetings
  • Internal liase with PD, R&D, QA, MRA,Clinical Ops manager. He/she is the interface for the product technical clinical escalated issues for a later esclation to mfgrer if needed. Collaborate with the data management and biostat plan.
  • Participate and approve CT reports
  • Participate in the required meetings and Commitees providing sound technical inputs

 

 

Who you are

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

 

  • You have a Bachelor's Degree in Health Sciences.
  • You have 3 - 5 years’ experience in Clinical Affairs
  • You have Advanced level of Spanish and English (C1) and of MS Office (Excel).
  • You have analytical skills, attention to detail, and ability to summarize and evaluate.

 

 

 

What we offer

 

It’s a brilliant opportunity for someone with the right talents.

Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We’ll help you grow professionally.

 

 

Information about Grifols is available at www.grifols.com. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.

We look forward to receiving your application.

 

Grifols is an equal opportunity employer.

 

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.

Benefits package

Contract of Employment: Permanent position

Flexibility for U Program: 2 days remote working

Location: APAC : China : Beijing:Beijing 

 

Learn more about Grifols