Job Details

Medical Affairs Manager, China

Req ID: R0027124
Category: Medical Affairs
Location: Shanghai, Shanghai CN

Posted Date: October 11, 2018

Job Description

Position Title: New product Medical advisor ( Sr. or MA manager)

Division:                     R&D

Location:                    Shanghai

Report to:                   Country Medical Head

Position purpose

This position has the responsibility to provide local medical input and support China local regulatory on product registration and dossier localization readiness.  Align with global and develop new product clinical plan, lead local cross functional cooperation and prepare pre-launch KOL partnership and improve their disease awareness. Ensure Chia pipeline products/ new indications registration and life cycle maintenance for responsible new product.

Major Responsibilities

Provide strategic and valuable medical analysis to support new product registration, possible trial waiver discussion or commitment study discussion locally and globally. Work with global and project team to ensure pipeline products/ new indications successful registration in China Responsible for defining strategic approach and managing preparation of medical sections of key Regulatory meetings and documents for CTA and NDA. Lead local study concept and provide valuable input to global study design. Lead the cross functional communications and alignments, as well as participant in global communication. Establish proactive and regular communication with global and local Build strong network with responsible disease key opinion leader

Qualifications

Education background

  • Clinical medical Degree or higher, minimum 5 years of pharmaceutical industry experience in clinical development team, with relevant clinical experience is preferred
  • Be familiar with China drug registration related regulatory and legal environment.
  • Flexible and able to work on multiple projects with aggressive timelines
  • Excellent team player with global mindset and multicultural environment
  • Excellent presentation, interpersonal, organization, communication and influencing skill
  • Fluent English and mandarin in both written and oral communication
  • Must be willing to travel as required

    Experience

  • > 3 year clinical experience, or > 3-5 year pharmaceutical company in clinical development or highly relevant positions

Stakeholders

Internal:

  • Global program team
  • China Regulatory Affairs
  • Clinical Development and Clinical Operations project team
  • Global safety team
  • Medical Affairs

External:

  • CFDA (China Food and Drug Administration)
  • CDE (Centre for Drug Evaluation)
  • External Thought Leader/ investigator
  • Ethic committee
  • Medical organizations/associations