General Counsel

Reporting to the Chief Executive Officer,the VP, General Counsel and Secretary will engage in a broad range of general corporate and securities-related work in support of strategic transactions, including diligence and deal requirements associated with product acquisitions and licenses. The General Counsel will take an active role overseeing and managing Harrow’s robust IP portfolio, including patents, patent applications, trademarks and other intellectual property. In addition, the General Counsel provides strategic advice and guidance on matters relating to regulatory issues relevant to a pharmaceutical company, including: advertising and promotion, scientific exchange, adverse event reporting, inspection and safety of facilities, communications with the FDA and other regulatory bodies, and quality issues. Further, this position ensures adherence to reporting requirements and regulatory issues such as filings made with the SEC, FDA and other regulatory agencies. As a key senior executive of the company, the General Counsel will ensure Harrow’s growth is governed by a clear, business-enabling legal framework that manages and anticipates organization risk.

Position Responsibilities

· Provide strategic direction to the Chief Executive Officer, the Executive Leadership Team and Board of Directors on all legal matters.

· Oversee corporate governance, including maintenance of corporate records for the company and securities law matters including, annual, quarterly and periodic reports filed with the SEC and other regulatory agencies (10-K, 10-Qs. 8-Ks, proxy statement, insider filings, etc.).

· Oversee and manage the company’s intellectual property portfolio, including working with outside counsel to ensure intellectual property is identified and protected.

· Correspond with FDA, other regulatory agencies, customers, suppliers, and division personnel as needed to address regulatory inquiries, problems, or requests.

· Direct and manage efforts related to audits, reviews and examinations, as needed to ensure compliance with all federal, state and local government regulations as applicable to the business.

· Review and revise the company’s promotional information and product literature to ensure FDA, FTC and state and/or local regulatory compliance.

· Lead implementation of enterprise risk assessments and mitigation plan, working closely with other members of the company’s executive leadership team and informing and advising the company’s Board of Directors as needed.

· Review government rulings and advisory opinions to determine changes and probable effects on facility activities.

· Draft, review and negotiate a broad range of contracts related to all aspects of the organization, including license agreements, collaboration agreements, clinical trial agreements, sponsored research agreements, material transfer agreements, supply agreements, master services agreements, consulting agreements and confidentiality agreements.

· Lead and coordinate the legal services provided by the legal team, ensuring consistency of legal advice on all issues, including healthcare fraud and abuse, FDA regulations on clinical trial conduct, labeling, advertising and pharmacovigilance, product liability, reimbursement, antitrust, privacy, and other matters relevant to the development, manufacture and commercialization of formulations and products.

· Help execute and maintain HIPAA and federal, state and international security compliance across all business units.

· Lead and coordinate the outside legal services provided, including selection and supervision of external corporate counsel, and evaluate the quality and costs of outside counsel.

· Develop and manage budgets for assigned legal matters.

· Advise the company on litigation risks of possible business decisions, manage and oversee threatened and actual litigation or other legal proceedings, and advise on appropriate strategy to defend or resolve litigation.

Requirements

· J.D. degree from an accredited law school, exceptional academic credentials and bar membership. Licensed to practice law in the United States and currently admitted to practice law in good standing with the State Bar of Tennessee.

· A minimum of 10 years of relevant experience in corporate and securities law, and FDA regulatory and health care law, including state boards of pharmacy, whether as in-house counsel and/or equivalent law firm experience.

· Experience in a pharmaceutical company with commercial operations is strongly preferred.

· Experience managing an intellectual property portfolio, including patents and trademarks.

· Knowledge of the Food Drug and Cosmetic Act (FDCA) and Drug, Quality and Security Act (DQSA).

· Solid critical thinker with a proven ability to collaborate with both leadership and teams, demonstrating an ability to influence, make sound decisions and drive alignment.

· Superior written and verbal communication skills.

· Excellent organization and time management skills, including ability to multi-task and manage a heavy workload with aggressive timelines.

· Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and Microsoft Office).

· Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.

· Ability to work in a fast-paced environment under pressure, meet deadlines and exercise sound business judgment with critical thinking skills.

· Natural leader with a positive management style, combined with superior communication skills and unwavering ethics and integrity.

· Ability to complete tasks with little direction or need for supervisory follow-up.

· Ability to travel up to 20% of the time. Must be able to travel independently as a Harrow Health, Inc. representative.

Qualifications

· The successful candidate must have the demonstrated ability to build and maintain relationships, trust, and respect with clients and peers, as well as the ability to proactively identify and manage significant legal issues.

· Strong leadership, technical knowledge, business acumen, and excellent communication skills are required.

· Candidate has a track record of effective decision-making and the proven ability to access, calibrate, and effetely communicate legal risk.

· Managerial courage required to counsel senior leaders. Ability to manage relationships with outside counsel and several regulatory agencies. Provide effective coaching and constructive feedback, as well as the organizational savvy and diplomatic sensitivities necessary to effectively collaborate with cross-functional client teams.

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. Occasional weekend, early morning and evening hours will be required.

AAP/EEO Statement

Harrow believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude and fostering a collaborative and mutually supportive environment.

Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation.

Harrow Health, Inc. is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.

Work Environment and Physical Demands

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job. This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions. While performing the responsibilities of the job, the employee is required to talk and hear. This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand as necessary.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time, with or without notice.