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A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Regulatory, Environment, Clinical Development and Global Supply (REG) Law team consists of four teams that handle a wide variety of legal matters for Pfizer: (1) the Regulatory Law team; (2) the Clinical Development team; (3) the Global Supply team; and (4) the Environmental, Health and Safety team.
This position reports into the U.S. Regulatory Law team, with responsibility for matters involving interpretation of key FDA-related legislation, regulations and policies, including counseling regarding regulatory exclusivity, product labeling and communications, and biosimilars; counseling of our Consumer Health business regarding marketing of OTC medicines and dietary supplements; counseling of the Pfizer Medical organization; and partnering with our Regulatory and Policy colleagues to advance legislative and regulatory initiatives important to Pfizer.
We are seeking an attorney who is interested in working in challenging, dynamic environment supporting a variety of client groups. Specific responsibilities may include:
- Counseling on matters regarding the various regulatory exclusivities available under U.S. law;
- Counseling on matters regarding the approval and marketing of biosimilar medicines;
- Partnering with Business Unit lawyers and Regulatory colleagues to develop enterprise-wide policies on product communications (both promotional and non-promotional);
- Counseling the Pfizer Medical organization in their efforts to increase the role of the patient in the drug development process, and educate patients about how to take a more proactive role in their health care decision-making;
- Counseling the Consumer Health business on questions regarding the approval and marketing on OTC medicines and dietary supplements; and
- Counseling on implementation of new legislative and regulatory requirements in Pfizer policies and procedures.
- Bachelor's degree and Juris Doctorate
- Member of a state bar/admitted to a relevant jurisdiction
- 10+ 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 involving counseling on regulatory exclusivity, and compliance with various FDA requirements including those in the areas of pharmacovigilance/benefit-risk, product labeling, and product communications.
- Self-motivated and able to perform role with minimal supervision
- Proven ability to proactively identify and analyze potential legal issues and develop creative and business focused legal advice and solutions
- Proven ability to cultivate strong client relationships and successfully influence leadership in a fast paced, innovative business environment
- 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
Equal Employment Opportunity
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.