1+ months

Legal Director, Asia R&D

Hedgesville, WV 25427

+ Provide regulatory compliance advice to clients in support of clinical development in China and, potentially, other Asian countries

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

+ Draft, maintain and advise on confidentiality agreements, template agreements, informed consents, SOPs and guidance documents

+ Lead support for negotiations on clinical trial-related transactions (including acquisition, licensing and collaboration agreements), informed consent forms and recruitment materials involving the listed countries

+ Evaluate and comment on changes in regulations and laws impacting clinical research in the Asia Pacific region, updating clinical trial-related agreements, forms 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.

+ Serve as lead attorney for escalation of legal issues involving clinical SOPs, contracts and regulations in China, and other countries as needed

+ 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 attorney is expected to independently advise clients on day-to-day legal issues. In addition, the attorney will have the ability to advise and influence across functions to ensure that legal issues are addressed.

Work collaboratively within the China-based legal teams and with other legal colleagues including those on the Clinical Development Legal team, as well as colleagues in Pfizer China and other Pfizer affiliates.

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

Must have the highest integrity and work ethic, be detail-oriented and be able to prioritize and manage multiple assignments.

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

Legal Affairs



Posted: 2021-01-08 Expires: 2021-03-10

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Legal Director, Asia R&D

Hedgesville, WV 25427

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