Senior Corporate Counsel

The Senior Corporate Counsel will provide strategic practical and business-oriented legal support across a broad range of company operations transactions and initiatives. This role serves as a trusted legal advisor to business leaders and cross-functional stakeholders delivering timely counsel on commercial operational compliance and risk management matters in a dynamic highly regulated environment. The Senior Corporate Counsel will support a pharmaceutical contract manufacturing organization (CMO)by helping structure review negotiate and manage complex legal arrangements and by promoting sound decision-making consistent with applicable law regulatory requirements and company policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide primary legal support for a broad range of commercial corporate operational and strategic matters across the organization with guidance tailored to a pharmaceutical CMO.
• Draft review negotiate and finalize a wide variety of agreements including master services agreements supply and manufacturing agreements quality-related agreements confidentiality agreements statements of work amendments and other customer vendors and partner arrangements.
• Advise business leaders and cross-functional stakeholders on legal regulatory compliance and risk considerations affecting business operations strategic initiatives and day-to-day decision-making.
• Identify assess and help manage legal and business risks while supporting the achievement of commercial objectives through practical solutions-oriented counsel.
• Support matters relevant to pharmaceutical operations including manufacturing supply chain quality regulatory data privacy and compliance-related issues as applicable.
• Develop update and deliver training policies templates and guidance materials to support compliance consistency and operational efficiency.
• Lead or support special projects internal investigations escalations and cross-functional initiatives at the direction of the General Counsel & Corporate Compliance Officer or other senior leadership.
• Manage a high volume of matters with competing priorities exercising sound judgment appropriate escalation and effective stakeholder communication.
• Collaborate effectively with internal teams and outside counsel and contribute to the continued enhancement of legal processes contract management practices and governance frameworks.

QUALIFICATIONS:

• J.D. or equivalent from an accredited law school and active membership in good standing in at least one state bar.
• Minimum of 10 years of relevant legal experience preferably combining law firm and in-house experience.
• Pharmaceutical or healthcare industry (Legal and/or Compliance) required.
• Broad knowledge of product development manufacturing and supply chain operations in a pharmaceutical company as well as the statutes regulations and guidance documents applicable to these activities (e.g. GxP EU and US FDA Regulations)
• Strong communication skills including the ability to convey complex legal and regulatory concepts clearly and effectively to non-legal stakeholders and senior leadership.
• Exceptional drafting negotiation analytical and issue-spotting skills with strong attention to detail and sound business judgment.
• Demonstrated ability to manage a substantial and varied workload in a fast-paced environment with competing priorities.