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THIS POSITION LOCATION CAN BE NEW YORK, NY; RINAT, CA; OR GROTON, CT
This position will provide legal support to Pfizer’s Global Product Development (GPD) organization, and other groups responsible for clinical trial quality management and oversight of clinical contract research organization (CRO) and other vendor performance, to ensure minimization of legal risks arising in execution of enterprise level and/or outsourced services for Pfizer’s global clinical trials. This position will also provide legal support to the Transparency group within Pfizer External Medical Affairs (EMA) on matters relating to clinical trial disclosure and data sharing.
This role will report to the Assistant General Counsel, Quality, Sponsor Oversight & Operations on the Clinical Development Legal Team which supports Pfizer clinical trial activities globally.
Provide regulatory compliance advice to clients across the clinical trial organization on matters pertaining to processes and procedures in support of clinical trials, with a particular emphasis on the relationship between sponsors, CROs and vendors
Advise on vendor quality and performance matters, and serve as legal representative on certain vendor governance committees
Provide legal input on selected clinical trial transactional matters, including updates to contract templates used by internal contracting groups in support of clinical trials; and evaluation of clinical trial-related contracts acquired through business acquisitions
Provide legal support on process and contractual matters relating to clinical trial disclosure and data sharing
Provide subject matter expertise, and legal support and guidance, on the development and application of standard operating procedures (SOPs) and related supporting procedural documents for clinical trial support activities
Provide ad hoc legal support on special projects as needed
Excellent academic qualifications including Bachelor’s Degree and Juris Doctor
Member in good standing of at least one state bar and admitted to practice in relevant jurisdiction
Minimum of 5 years’ experience in the pharmaceutical or biotech industry, or at a law firm supporting clients in the pharmaceutical or biotech industry, preferably including some or all of the following: FDA regulatory compliance, Good Clinical Practice (GCP), outsourcing transactions, contract template management
Strong interest in, and commitment to, the legal subject matter relevant to this role
Excellent research, writing, counselling and communication skills (formal and informal) and a positive client service orientation
Ability to work independently, as a team member, and across the organization
Accountability, sound judgment, and the ability to take ownership of an issue and provide concise and timely advice
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
For Groton and Rinat applicants, this role would require some travel to New York headquarters (NYHQ) during an initial training period, and periodic travel to NYHQ following that.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.