Corporate Counsel, Contracts

Harmony Biosciences is recruiting for a Corporate Counsel, Contracts role in our Plymouth Meeting, PA location. 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.

Responsibilities include but are not limited to:

• 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 healthcarerelated 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 riskmanagement 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.

Qualifications:

• 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

Physical demands and work environment:

• Domestic travel is estimated to be 10% of the time for this position.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.

What can Harmony offer you?

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

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