Description:
Job Description - The Director, Assistant General Counsel – Products, Quality and Commercial Operations provides strategic legal counsel to Owens & Minor's Products business and related commercial, quality, regulatory, supply chain, procurement, and operational functions. The role independently manages complex legal matters, advises senior business leaders, and partners across functions to support business objectives while mitigating legal, regulatory, operational, and reputational risk. The Director leads legal support for significant commercial, product, regulatory, and operational initiatives within assigned areas of responsibility.The anticipated salary range for this position is $180,000 - 200,000 annually plus 20% AIP eligibility. The actual compensation offered may vary based on job related factors such as experience, skills, education and location. The ideal candidate will reside in Virginia or Georgia.
Core Responsibilities -
Strategic Legal Partnership
- Serves as a primary legal partner for assigned areas within Owens & Minor's Products business and related functions.
- Provides strategic and practical legal counsel to senior business and functional leaders on complex commercial, operational, regulatory, product, and quality matters.
- Evaluates business initiatives and develops legal recommendations that balance business objectives, regulatory requirements, and risk.
- Leads legal support for significant initiatives involving new products, market expansion, strategic partnerships, sourcing strategies, and commercialization activities.
- Anticipates emerging legal, regulatory, and operational risks and advises stakeholders on appropriate mitigation strategies.
- Escalates matters involving significant enterprise, financial, regulatory, or reputational exposure to senior Legal leadership as appropriate.
Commercial Contracting
- Leads the drafting, review, negotiation, and interpretation of complex commercial agreements supporting the Products business.
- Negotiates product supply, supplier, manufacturer, procurement, sourcing, customer, and strategic commercial agreements.
- Advises on Group Purchasing Organization (GPO), channel, private label, contract manufacturing, raw material sourcing, kitting, assembly, and related commercial arrangements.
- Provides legal guidance on quality agreements and contractual provisions involving product, manufacturing, supplier, and operational requirements.
- Develops negotiation strategies and legal risk positions for complex or high-value commercial transactions.
- Develops and improves contract templates, standards, playbooks, and processes to increase consistency and efficiency.
Product Regulatory and Compliance
- Provides legal counsel regarding healthcare products and applicable FDA and other product-related regulatory requirements.
- Advises on legal and regulatory considerations involving product development, sourcing, commercialization, labeling, product claims, promotional materials, lifecycle management, complaints, recalls, and corrective actions.
- Evaluates legal and regulatory risks associated with new products, product changes, marketing strategies, and commercialization activities.
- Partners with Regulatory Affairs, Quality, Compliance, Product Management, and business leaders to address complex product compliance matters.
- Interprets applicable legal and regulatory requirements and provides practical guidance to business stakeholders.
Supply Chain and Procurement
- Provides legal counsel on complex sourcing, procurement, supplier, manufacturing, and supply chain matters.
- Leads legal support for significant supplier negotiations and strategic sourcing initiatives.
- Advises on supplier performance, continuity of supply, sourcing changes, manufacturing arrangements, product availability, and related contractual risks.
- Identifies and addresses legal and commercial risks associated with critical supplier relationships and supply chain disruptions.
- Partners with Procurement and Supply Chain leaders to develop practical risk mitigation strategies.
Marketing and Commercial Review
- Provides legal guidance regarding marketing materials, advertising, product claims, promotional campaigns, customer communications, and commercialization strategies.
- Advises on claim substantiation, regulatory requirements, product positioning, and related legal risk.
- Supports Product Management and Marketing leaders on product launches and significant commercial initiatives.
- Develops practical guidance that enables compliant and effective commercial communications.
Quality and Product Stewardship
- Serves as a senior legal resource to the Quality organization on significant product and quality-related matters.
- Advises on product testing, validation, quality agreements, complaints, corrective actions, recalls, and other product quality issues.
- Evaluates legal risk associated with product quality matters and recommends appropriate response strategies.
- Partners with Quality, Regulatory Affairs, Compliance, and Operations to resolve complex product and quality concerns.
- Leads legal support for significant quality-related investigations and remediation activities within assigned areas.
Risk Management and Dispute Resolution
- Identifies, evaluates, and manages complex legal, commercial, regulatory, and operational risks associated with assigned business activities.
- Develops legal strategies to prevent and resolve disputes involving suppliers, customers, products, quality matters, and commercial agreements.
- Leads or supports internal investigations involving assigned areas of legal responsibility.
- Manages legal aspects of significant claims, regulatory inquiries, and disputes in coordination with senior Legal leadership.
- Directs and manages outside counsel on assigned matters as appropriate.
- Provides timely recommendations to senior stakeholders regarding dispute resolution and risk mitigation.
Leadership and Cross-Functional Influence
- Leads complex legal projects and cross-functional workstreams involving multiple business and functional stakeholders.
- Provides leadership, guidance, and subject-matter expertise to business partners and less-experienced legal professionals as appropriate.
- Influences senior stakeholders through sound legal judgment, business acumen, and practical recommendations.
- Builds strong partnerships across Legal, Compliance, Regulatory Affairs, Quality, Product Management, Commercial, Supply Chain, Procurement, Marketing, and Operations.
- Promotes consistent legal practices, effective decision-making, and appropriate risk management across assigned areas.
- Demonstrates leadership through ownership of complex matters, stakeholder alignment, and execution of strategic legal initiatives.
Process Improvement and Capability Development
- Develops and implements legal processes, tools, templates, playbooks, and training that improve efficiency and strengthen risk management.
- Leads training and education for business stakeholders on relevant legal, regulatory, and contracting matters.
- Identifies opportunities to improve legal service delivery, contracting practices, and business processes.
- Supports continuous improvement initiatives across Legal and supported business functions.
- Shares knowledge, best practices, and legal guidance to strengthen organizational capability.
- Demonstrates excellent guest service to internal team members.
- Performs other related duties as assigned.
Qualifying Experience -
- Juris Doctor (J.D.) degree from an accredited law school.
- Active license and good standing to practice law in at least one U.S. jurisdiction.
- 12 + years of progressively responsible legal experience, including substantial experience supporting healthcare, medical products, pharmaceutical, manufacturing, distribution, or other regulated businesses.
- Demonstrated leadership experience managing complex legal matters, leading cross-functional initiatives, and influencing senior business stakeholders.
- Demonstrated experience independently managing complex commercial, regulatory, operational, and business legal matters.
- Extensive experience drafting, reviewing, and negotiating complex commercial agreements.
- Experience advising senior business and functional leaders on strategic, operational, and risk-related matters.
- Experience advising business and functional leaders on matters involving regulated products, commercial operations, quality, regulatory, procurement, supply chain, or related functions.
- Strong knowledge of FDA-regulated products and related legal and regulatory requirements.
- Demonstrated ability to evaluate complex legal risk and provide practical, business-oriented recommendations.
- Demonstrated ability to lead significant projects, workstreams, or legal matters with a high degree of independence.
- Strong judgment, negotiation, analytical, communication, and stakeholder management skills.
- Ability to manage multiple complex priorities in a dynamic business e
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