Shire Medical Affairs Manager, China in Shanghai, China

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

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.