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Corporate Counsel -- Regulatory Law and Clinical Development Legal
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | new york, New York |
About this job
Org Marketing Statement
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.
Role Description
The Regulatory, Environmental & Global Supply (REG) Law group consists of four teams that support a wide variety of legal matters for Pfizer: (1) the Regulatory Law team, (2) the Clinical Development Legal team, (3) the Global Supply team, and (4) the Environmental, Health and Safety team. This position will provide legal support to the Regulatory Law team and the Clinical Development Legal team on matters relating to clinical trial quality, vendor oversight, Good Clinical Practice (GCP) and Pharmacovigilance inspections, and related matters in support of Pfizer's global clinical trials and pharmacovigilance system.
This role will report to the Senior Corporate Counsel for Pharmacovigilance and Regulatory on the Regulatory Law team, and have a dotted line report to the Senior Corporate Counsel for Sponsor Oversight and Quality on the Clinical Development Legal team.
Responsibilities
We are seeking an attorney who is interested in working in a challenging, dynamic environment, supporting a variety of client groups in matters involving regulatory compliance in the areas of pharmacovigilance and clinical trials, as well as clinical trial quality and other clinical development matters. Specific responsibilities may include:
* Supporting Senior Corporate Counsel, Pharmacovigilance and Regulatory in connection with inspection readiness activities and FDA Good Clinical Practice (GCP) and pharmacovigilance inspections
* Supporting Senior Corporate Counsel, Pharmacovigilance and Regulatory in connection with drafting regulatory correspondence and submissions, including Form FDA 483s
* Supporting Senior Corporate Counsel, Sponsor Oversight and Quality on resolving legal questions escalated from the Legal Operations team relating to clinical trial contracting and vendor oversight.
* Supporting Senior Corporate Counsel, Pharmacovigilance and Regulatory and Senior Corporate Counsel, Sponsor Oversight and Quality in the review of standard operating procedures (SOPs), SOP revisions and SOP deviation requests for clinical trial, pharmacovigilance, regulatory and other related policies and procedures
* Participating as an alternate member/delegate for Senior Corporate Counsel, Pharmacovigilance and Regulatory and Senior Corporate Counsel, Sponsor Oversight and Quality on oversight and governance committees including the Oversight Quality Review Team (OQRT)
Qualifications
* Bachelor's Degree and Juris Doctorate
* Member of a State Bar / Admitted as an attorney in relevant jurisdiction
* Five to seven years of experience in the pharmaceutical or biotech industry, or at a law firm supporting clients in the pharmaceutical or biotech industry, preferably including matters relating to the clinical development process, commercial contract drafting and negotiation, FDA regulatory compliance and inspection support in regulatory, pharmacovigilance and clinical practice areas
* Excellent communication and writing skills
* Flexibility to travel as needed
* Ability to handle multiple demands and priorities simultaneously
* Ability to collaborate, influence and work across as well as participate in matrix teams
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.
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.
Role Description
The Regulatory, Environmental & Global Supply (REG) Law group consists of four teams that support a wide variety of legal matters for Pfizer: (1) the Regulatory Law team, (2) the Clinical Development Legal team, (3) the Global Supply team, and (4) the Environmental, Health and Safety team. This position will provide legal support to the Regulatory Law team and the Clinical Development Legal team on matters relating to clinical trial quality, vendor oversight, Good Clinical Practice (GCP) and Pharmacovigilance inspections, and related matters in support of Pfizer's global clinical trials and pharmacovigilance system.
This role will report to the Senior Corporate Counsel for Pharmacovigilance and Regulatory on the Regulatory Law team, and have a dotted line report to the Senior Corporate Counsel for Sponsor Oversight and Quality on the Clinical Development Legal team.
Responsibilities
We are seeking an attorney who is interested in working in a challenging, dynamic environment, supporting a variety of client groups in matters involving regulatory compliance in the areas of pharmacovigilance and clinical trials, as well as clinical trial quality and other clinical development matters. Specific responsibilities may include:
* Supporting Senior Corporate Counsel, Pharmacovigilance and Regulatory in connection with inspection readiness activities and FDA Good Clinical Practice (GCP) and pharmacovigilance inspections
* Supporting Senior Corporate Counsel, Pharmacovigilance and Regulatory in connection with drafting regulatory correspondence and submissions, including Form FDA 483s
* Supporting Senior Corporate Counsel, Sponsor Oversight and Quality on resolving legal questions escalated from the Legal Operations team relating to clinical trial contracting and vendor oversight.
* Supporting Senior Corporate Counsel, Pharmacovigilance and Regulatory and Senior Corporate Counsel, Sponsor Oversight and Quality in the review of standard operating procedures (SOPs), SOP revisions and SOP deviation requests for clinical trial, pharmacovigilance, regulatory and other related policies and procedures
* Participating as an alternate member/delegate for Senior Corporate Counsel, Pharmacovigilance and Regulatory and Senior Corporate Counsel, Sponsor Oversight and Quality on oversight and governance committees including the Oversight Quality Review Team (OQRT)
Qualifications
* Bachelor's Degree and Juris Doctorate
* Member of a State Bar / Admitted as an attorney in relevant jurisdiction
* Five to seven years of experience in the pharmaceutical or biotech industry, or at a law firm supporting clients in the pharmaceutical or biotech industry, preferably including matters relating to the clinical development process, commercial contract drafting and negotiation, FDA regulatory compliance and inspection support in regulatory, pharmacovigilance and clinical practice areas
* Excellent communication and writing skills
* Flexibility to travel as needed
* Ability to handle multiple demands and priorities simultaneously
* Ability to collaborate, influence and work across as well as participate in matrix teams
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.