1+ months

Senior R&D Legal Counsel

Pfizer
Hedgesville, WV 25427
**ROLE SUMMARY**



+ The attorney in this position has key accountability to recognize legal issues and advise on a broad range of clinical trial-related issues in China including negotiation of clinical research agreements and clinical trial execution matters across the Asia-Pacific region. The role also includes advising on more general legal issues arising in the Pfizer Development China group and other Pfizer groups responsible for clinical trial conduct, including oversight of CROs and other vendors.

+ The geographical scope of the role is across the Asia-Pacific region including China, Korea, Singapore, Australia and New Zealand and other Asian countries, except Japan, with a particular focus on China.

+ This role will report to the lead counsel, Asia R&D who is based in Shanghai.



**ROLE RESPONSIBILITIES**



+ Provide legal support, advice and analysis on clinical trial conduct and quality issues and clinical vendor and site performance matters (e.g., adverse events, inspections, sample collection, post-study drug access, article publications, and audits

+ Draft, maintain and advise on template agreements, informed consents, SOPs and guidance documents; lead or provide support for negotiations on clinical trial-related transactions, informed consent forms and recruitment materials involving the listed countries

+ Evaluate and comment on changes in regulations and laws impacting clinical research in Asia Pacific, updating clinical trial-related agreements and guidance documents as needed

+ Interact with governmental authorities, trial sites and others regarding regulatory affairs, research injuries, export and import issues, inspections, self-assessments, etc.

+ Provide subject matter expertise, legal support and guidance for the development and application of SOPs and related documents for clinical trial support activities

+ Provide ad hoc legal support on special projects as needed



The Senior R&D Counsel is expected to have sufficient experience and judgment to independently advise clients on day-to-day legal issues. In addition, the Counsel will need the ability to advise and influence across functions to ensure that legal issues are addressed.



Work collaboratively within teams and also in interactions with other legal colleagues in the Global Clinical Development Legal Team, Pfizer China and other Pfizer Affiliates.



Demonstrate strong organizational, interpersonal and communication skills in Mandarin Chinese and English.



Must be detail-oriented and be able to prioritize and manage multiple assignments.



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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Posted: 2019-08-27 Expires: 2020-01-03

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Senior R&D Legal Counsel

Pfizer
Hedgesville, WV 25427

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