Counsel, Law - Litigation

Berkeley Heights NJJob Type: Full-TimeAbout Us:As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description:We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Counsel, IP and Litigation individual to join our team. In this role you will be responsible for providing overall strategic as well as day-to-day IP and litigation support to Hikma’s North American pharmaceutical injectables and non-injectable business. This position will work closely with the research & development team with product selection, product development and design, obtaining patent and trademark protection or clearance, regulatory approval, and launch. This position will also provide general IP and litigation counselling and will manage outside law firms in connection with IP and litigation matters and will negotiate settlements of disputes where appropriate. It is expected that the person will have a significant experience with the pharmaceutical industry and have deep understanding of the overall regulatory framework under which a generic manufacturer generates ANDA, 505(b)(2), aBLA filings, including the Hatch Waxman Act and the BPCIA. Manage the development of US patent strategies during noninjectable and injectables API selection, product selection, and pipeline development through launch. Work with R&D scientists, regulatory, commercial, and management teams to provide quick and accurate IP and other legal advice on all aspects of the Hatch-Waxman Act, including the timing of product approvals and launches.Oversee outside counsel and patent litigation including coordinating discovery, expert retention, and providing substantive input on legal strategies and settlement negotiations. Provide advice to management on litigation strategy, launch scenarios, and settlements. Manage outside counsel in all areas of general litigation including commercial contracts, products liability, employment, and other matters, from discovery through trial and appeal. Manage discovery, document collection, and related matters; provide substantive input on legal strategies and settlements and succinctly advise management regarding the same. Provide input and assistance to other departments and counsel on the proper approach to matters involving potential litigation or the risk of litigation.Assist with developing regulatory strategies for new products including 505(b)(2) and ANDA products.Work with business development teams to conduct IP and regulatory due diligence. Provide IP and legal advice on business development deals, including licensing, co-development, marketing, and product acquisitions. Review and edit BD contracts with a practical awareness of both legal and business risks. Assist with IP and regulatory due diligence on M&A deals.Work with R&D and commercial teams to identify new opportunities for patent and trademark protection. Implement and train on legal policies and special legal initiatives.A Juris Doctor (JD) degree from an ABA accredited law school, admission to practice law in a U.S. jurisdiction with the ability to qualify for additional in-house licenses as needed.Strong academic credentials, including a bachelor’s or graduate level degree in a relevant scientific background; a license to practice before the USPTO or substantial intellectual property practice experience, preferably in Hatch-Waxman and BPCIA litigation; Minimum: More than 7 years’ experience which should include experience with a top law firm, preferably representing global pharmaceutical and/or life science clients. Prior in-house experience with a global pharmaceutical or other life science company is desirable.Preferred: USPTO registration or the ability to be qualified for such registration.Excellent analytic, legal drafting and oral and written communication skills and ability to lead a must.Ability to work efficiently, to prioritize workflow, to meet demanding deadlines, to work with cross-functional groups in a multicultural environment, and to manage multi-dimensional projects in a fast-paced environment.Up to 10% -15% travel is required.The candidate must be capable of building strong, lasting and effective business relationships, and cultivating and maintaining the position of trusted advisor to stakeholders within Hikma.What We Offer*:Annual performance bonus, commission, and share potentialAuto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Additional days granted upon reaching work milestone anniversaries3 personal days (prorated based on hire date)11 company paid holidaysComprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefitsEmployee discount programWellbeing rewards programSafety and Quality is a top organizational priorityCareer advancement and growth opportunitiesTuition reimbursementPaid maternity and parental leave*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.