Senior Counsel - Regulatory Life Science

at  Philip Morris International

CRITICAL SKILLS

• Expertise in regulatory frameworks and healthcare compliance.
• Strong problem-solving skills and the ability to identify and mitigate legal risk associated with products under assessment and development.
• A passion for collaboration and consensus.
• Drives the appropriate level of external benchmarking of best practices.
• Maintains a culture and collaborates with a high degree of emphasis on dignity, respect, and inclusion.
• Robust interpersonal and writing skills, with the confidence and credibility to act quickly, communicate effectively with diplomacy and civility, and command respect of both internal and external audiences.
• Exceptional ability to analyze legal issues, develop legal strategies, and provide innovative solutions
• Proven ability to negotiate complex legal documents and contracts with a keen eye for detail

PURPOSE OF THE ROLE

Senior Counsel who will be effective in providing regulatory, product classification, and pharmaceutical process and legal compliance guidance to business and key stakeholders across the organization with responsibility for performing a variety of legal matters of varying complexity; leading projects as assigned including day-to-day advice to the company and its business professionals on a range of potential pharmaceutical or healthcare products, including but not limited to: NRT, cannabinoid, smoke-free, supplements, wellness and consumer health products. This role will focus on supporting the life sciences and commercial teams in the scientific assessment, commercial deployment (wellness and consumer health products), regulatory compliance and pharmacovigilance, as well as supporting the teams engaging in government interactions and regulatory engagement; including on a reputational, regulatory or administrative guidance, contractual, and commercial transactions standpoints.
PMI is seeking an experienced regulatory attorney who is steeped in healthcare or pharmaceutical regulatory issues, with a broad-based background on regulated devices and substances, substantial leadership experience, and an established regulatory network who will be effective in exercising seasoned judgment and providing guidance to business and functional leaders across the Company. Reporting to the VP Associate General Counsel – Regulatory, this role will require a person of vision, integrity, commitment, maturity, judgment, as well as substantial leadership experience.

KEY RESPONSIBILITIES

• Provides legal support to the scientific assessment of PMI’s pharmaceutical, supplement, or consumer products.
• Leads the regulatory pathway assessment and supports the go forward planning for commercial deployment of Company’s Pharma portfolio of wellness and consumer health products
• Drafts, reviews, and negotiates a wide range of agreements, including clinical trial, research collaboration, license, distribution, standard operational procedures, and vendor contracts, while identifying and mitigating risks and balancing business interests.
• Partners with internal clients to support projects in particular coming from PMI’s scientific activities in Life Sciences and pharma subsidiaries with a view to mitigate potential liabilities and risks.
• Helps business partners accurately understand the risks and consequences of the given situation or course of action.
• Proactively identifies and analyzes legal issues and risks, drafts key documents, presents clear recommendations and ensures legal compliance as it relates to the noted areas of law.
• Stays current with legal developments, best practices and benchmarks in the noted areas of law and assists internal clients in implementing policies and procedures in response thereto.
• Review of scientific publications and briefs, and material related to scientific research and collaboration
• Conducts legal assessment relevant for projects in Life Sciences and VFP
• Closely and timely cooperates with other PMI COEs, in particular the Litigation, IP, Product Development, Regulatory, and Commercial Deployment law teams.
• Oversees corporate interaction with global regulatory bodies, to include the U. S. Food and Drug Administration (FDA).
• Provides advice and guidance on healthcare laws and regulations applicable to the development and commercialization of PMI’s products in North America.
• Collaborates and participates on cross-functional teams for product labeling, product development teams, medical affairs, and marketing.
• Provides advice on healthcare regulatory matters, including commercial, clinical development, medical affairs, patient safety, regulatory, and healthcare compliance.
• Reviews and provides guidance on a wide range of promotional and non-promotional materials, including branded promotional materials, disease education/disease awareness campaigns, scientific communications, speaker programs, patient education materials, grants and sponsorships, training materials, and reprint and publications plans.
• Counsels on appropriate relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, consistent with relevant healthcare laws and trends.
• Supports market access activities, including pricing committee, government price reporting and price transparency laws, patient support programs, supply chain and distribution, patient hubs, and other complex pricing and reimbursement strategies (e.g., value-based contracting).
• Reviews and advises on healthcare regulatory matters in PMI’s external communications, such as scientific journal articles, abstracts, presentations at medical conferences, press releases, and investor presentations, and participate in internal / external working groups and government affairs activities.
• Advises and trains on the EU and US laws or equivalents of Food, Drug and Cosmetic Act, anti-kickback and false claims statutes, OIG advisory opinions and fraud alerts, FDA guidance documents, product liability laws, healthcare related privacy laws, industry codes and standards (e.g., PhRMA, ICMJE, ACCME, etc.), and other laws and regulations applicable to the development and commercialization of pharmaceutical products (RX, OTC, and other categories).
• Assists with the development and implementation of policies and procedures related to healthcare compliance, including interactions with healthcare professionals, speaker programs, patient access and reimbursement support, expanded access, advisory boards, market access, and activities at scientific congresses.