Role Summary:
The Global Product Counsel (“GPC”) for the Rare Disease business of Pfizer Biopharmaceutical Group (“PBG”) will primarily serve as the Lead Risk Counselor and interface for products and investigational assets in business unit.
In this role, the GPC will provide legal guidance and counsel to business and cross-functional teams in a matrixed corporate environment that requires an enterprise mindset and effective collaboration with internal legal subject-matter experts and key cross-functional stakeholders.
Role Responsibilities:
Operate as the Lead Risk Counselor and interface for assigned in-line and pipeline products on a global basis along with other related legal and leadership responsibilities in support of the PBG;
Understand the strategic and tactical objectives of the commercial, medical, development, and community/patient engagement teams and develop creative and thoughtful solutions to key initiatives, taking into account current legal and regulatory landscapes, Pfizer policies and procedures and the current and future needs of the PBG and Pfizer as a whole;
Support medical and commercial development for assigned products, including:
Regulatory and medical strategies
Product safety and risk-mitigation activities
Label development
Market development
Product communication activities
Proactive benefit: risk development and maintenance, including Medical Governance activities
Collaborate with international platform colleagues on portfolio business strategies and practices being implemented in their markets;
Support US marketing and sales for assigned products, including:
Advertising and promotion and all product communication strategies
Healthcare law compliance
Risk assessment and mitigation planning
Ongoing compliance monitoring;
Ensure compliance with legal policies and procedures, controls and statutory requirements within relevant business areas.
Work constructively and collaboratively with other members of Pfizer’s Legal Division, legal staff, business colleagues and compliance professionals.
Demonstrate strong organizational, interpersonal, and communication skills as well as sound judgment with a high level of professionalism and minimal supervision. Must possess leadership skills and be detail-oriented, a quick learner, and able to work effectively in a highly matrixed organization.
Ability and willingness to:
Gain deep understanding of business strategies and actively counsel on business and legal approaches and opportunities
Devise and deliver tailored education programs to key client groups on a range of legal, policy and compliance matters
Anticipate, develop and advocate positions on important regulatory policy and external environment matters impacting Pfizer’s business objectives
Build networks throughout the Pfizer Legal Division and the company, and receive input from and collaborate with attorneys and other colleagues providing platform services, including colleagues supporting procurement, patent law, litigation, regulatory, medical, commercial business units, R&D and compliance
Track record of accountability and sound judgment, including the ability to take ownership of and move projects to closure
Excellent drafting and negotiation skills with an eye for detail combined with pragmatism/sound judgment
Excellent communication skills to convey complex legal issues to clients in a clear and concise manner
Basic Qualifications:
The successful candidate must have the following qualifications, skills and attributes:
Strong Leadership Skills and the ability to support Team Leaders within the organization
Strong academic background, Bachelor’s Degree and Juris Doctorate or equivalent law degree
7+ years legal and/or compliance in the pharmaceutical or biotech industry, including experience in regulatory law and commercial/medical-related matters.
Demonstrated ability to grasp statutory and regulatory concepts quickly, and to proactively identify and analyze potential legal issues and provide thoughtful and creative business-focused legal advice and solutions.
Proven capacity to cultivate strong client relationships and successfully influence leadership in a fast-paced, innovative business climate.
A thorough understanding of regulatory and legal frameworks governing the sales and marketing of approved medicines, and regulatory framework for investigational medicines.
Must Have:
The successful candidate must have the following qualifications, skills and attributes:
Strong academic background, Bachelor’s Degree and Juris Doctorate or equivalent law degree
10+ years legal and/or compliance in the pharmaceutical or biotech industry, including experience in regulatory law and commercial/medical-related matters.
A thorough understanding of regulatory and legal frameworks governing the sales and marketing of approved medicines, and regulatory framework for investigational medicines.
Strong Leadership Skills and the ability to support Team Leaders within the organization
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Nice to Have:
Proven capacity to cultivate strong client relationships and successfully influence leadership in a fast-paced, innovative business climate.
Demonstrated ability to grasp statutory and regulatory concepts quickly, and to proactively identify and analyze potential legal issues and provide thoughtful and creative business-focused legal advice and solutions.
Track record of accountability and sound judgment, including the ability to take ownership of and move projects to closure
Excellent drafting and negotiation skills with an eye for detail combined with pragmatism/sound judgment
Strong leadership skills
Other Job Details:
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.