Corporate Counsel, Contracts

Harmony Biosciences LLCPlymouth Meeting, PA
3dHybrid

About The Position

This is an in-house legal role responsible for working with teams across the organization on a broad spectrum of legal needs, with an emphasis on clinical trial agreements and related documentation. It requires strong knowledge of the pharmaceutical and biotechnology landscape, including FDA and other regulatory frameworks, clinical development, healthcare compliance, strategic partnerships, complex vendor arrangements, and corporate legal matters. The position will partner with the business to educating others on legal issues and ensuring compliance with company policies to address challenges and move work forward.

Requirements

  • Juris Doctor (JD) degree from accredited law school, including bar admission within one or more U.S. state(s) required
  • 5+ years of legal practice experience required, with experience in FDA regulatory, clinical development, healthcare compliance or contracts drafting and negotiation experience strongly preferred; in a law firm and/or in-house biotech/pharmaceutical company
  • Demonstrated solid judgment, particularly in determining the significance of legal matters and when to elevate them to the Senior Director, Legal Affairs, and in effectively measuring and minimizing risks
  • Strong organizational skills in order to prioritize and manage multiple time-sensitive projects simultaneously; willingness to assume a heavy workload to meet timing and project needs
  • Ability to take on large projects, create and present a plan of action, and independently manage projects to favorable resolution or conclusion
  • Ability to maintain high level of integrity of confidential and sensitive information and credibility within the organization
  • High ethical and quality standards and lives them through actions and communication
  • Demonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problems
  • Strong computer, organizational, and analytical skills required

Responsibilities

  • Partner with Clinical Operations to address clinical trial related issues and lead the drafting, negotiation, and completion of key study documents, including ICFs, CRO agreements, and CTAs.
  • Support regulatory and scientific teams by interpreting FDA requirements and other global regulatory expectations.
  • Guide Compliance and business stakeholders on internal policies, including corporate governance standards and healthcare‑related procedures such as HCP engagement.
  • Oversee a wide range of commercial and vendor relationships by preparing, negotiating, and finalizing agreements, with a focus on consulting, purchasing, supply, licensing, and master service arrangements.
  • Provide strategic legal insight to help the organization achieve its objectives while maintaining adherence to applicable laws, regulations, and risk‑management principles.
  • Build a strong understanding of the company’s operations, technologies, markets, and competitive landscape to anticipate legal needs and shape effective business and legal strategies.
  • Stay current on laws and regulations impacting the pharmaceutical and healthcare industries, advises on legal rights under contracts, compliance requirements and regulatory submissions, as needed; Collaborates with internal stakeholders to ensure adherence to local, state and federal laws and regulations
  • Collaborates with internal departments including, but not limited to: Commercial, Finance, Human Resources (HR), Regulatory Affairs and Compliance, to provide legal guidance and support on laws, regulations, standard operating procedures and company policies affecting business
  • Perform other duties as assigned.
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