At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
Shire Medical Affairs Manager, China in Shanghai, China
Position Title : New product Medical advisor ( Sr. or MA manager)
Report to: Country Medical Head
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.
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
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
Global program team
China Regulatory Affairs
Clinical Development and Clinical Operations project team
Global safety team
CFDA (China Food and Drug Administration)
CDE (Centre for Drug Evaluation)
External Thought Leader/ investigator
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.