Imprimis Pharmaceuticals is Hiring a Regulatory Corporate Counsel

Regulatory Corporate Counsel

Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a San Diego-based specialty pharmaceutical company focused on the development and commercialization of proprietary and novel sterile and topical drug formulations. Certain of Imprimis’ patent-pending drug formulations are available today and are being prescribed by physicians. For more information, please visit www.imprimispharma.com
 Job Summary
Responsibilities will include counseling and reporting requirements on regulatory issues such as FDA and State Pharmacy laws and regulations, guidance documents relating to pharmaceutical advertising and promotion, scientific exchange, handling adverse events including regulatory actions and violations; and regulatory agency strategy on inspectional and safety issues, communications, and quality issues. Responsibilities also include counseling on fraud and abuse issues relating to sales and marketing activities, including the Anti-kickback Statute and False Claims Act, as well as contract and pricing strategies such as discounts, rebates, and bundling methodologies. Researches FDA, FTC, DEA, DOJ, CBP, and State BOP regulations, case law and statutes pertaining to regulatory agencies and the administrative process. Supports business processes concerning specific legal-FDA regulatory matters and issues. This position reports to the Vice President of Accounting and Public Reporting.
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 assess, calibrate, and effectively communicate legal risk.  You must have the managerial courage required to counsel senior leaders, manage relationships with outside counsel and several regulatory agencies, including but not limited to, state boards of pharmacy and the FDA, and 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 Responsibilities: 

• Correspond with the State Pharmacy Boards, FDA, other regulatory agencies, customers, suppliers, and division personnel as needed both orally and in writing to address regulatory inquires, problems, or requests.
• Identify, recommend and implement where possible, corrective actions for regulatory and other related processes.
• Review promotional information and product literature to ensure FDA and FTC regulatory compliance.
• Review governmental rulings to determine changes and probable effects on facility activities.
• Draft 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.
• Oversees legal services provided by the practice group and helps ensure consistency of legal advice on healthcare law 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 security compliance across all business units
• Collaborate with all necessary parties to achieve desired business outcomes, works closely with Vice President of Pharmacy Operations.
• Excellent organization and time-management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure.
• Assist on other matters within the legal department as needed.
• Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
• Coordinate with outside counsel as appropriate.
• Develops and manages budgets for assigned legal matters.
• Resolve contract disputes.
• Contribute to the constant improvement of the internal contracting process.

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 and in good standing as a lawyer in the state of California.
• Licensed pharmacist preferred
• 5 or more years of relevant experience in FDA regulatory law area and state boards of pharmacy
• Knowledge of DQSA
• Strong written, verbal and presentation communication skills.
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and Microsoft Office) required.
• Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
• Team player with a positive, can-do attitude.
• Ability to complete tasks with little direction or need for supervisory follow-up.
• Ability to travel up to 10% of the time. Must be able to travel independently as an Imprimis Pharmaceuticals, Inc. representative.

Work Environment/Physical Demands:

• The employee may frequently be required to sit and talk or hear.
• The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch.
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

Imprimis 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 race, color, religion, sex, national origin, protected veteran status, or disability status.
Imprimis Pharmaceuticals, 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.