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Counsel, IP and Litigation
4 months ago
About Us:
For over 40 years Hikma Pharamceuticals US Inc. and our affiliates have been creating high-quality medicines and making them accessible to the people who need them. 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, MENA and Europe. We have 32 manufacturing plants, 8 R&D centers and c8,800 employees worldwide.
Description:
The IP & Litigation Counsel provides 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. This position will additionally provide substantive guidance, diligence, and input on business development transactions and acquisitions. 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.
Responsibilities:
* Ability to juggle multiple matters in an organized manner without losing track of any of them. Dependable and timely work product.
* 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. Negotiate 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. Assist in the development, management, and coordination of Hikma's patent and trademark portfolio.
* Implement and train on legal policies and special legal initiatives.
Qualifications:
* 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; extensive knowledge of the Hatch-Waxman Act, the BPCIA, and related regulations and practices.
* 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: More than 10 years' experience.
* 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.
* Hybrid work schedule: With a requirement to work a minimum of 3 days in the office per week.
* 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 potential
* 401k employer match, up to 6% of your contributions
* 20 paid time off days (prorated based on hire date)
* 3 personal days (prorated based on hire date)
* 11 paid holidays
* Generous healthcare benefits, including health, disability, dental, vision, and life insurance.
* Employee discount program
* Wellbeing rewards programs
* Safety and Quality is a top organizational priority.
* Career advancement and growth opportunities
* Tuition reimbursement opportunities
* Paid maternity and parental leave
* Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Location:
Berkeley Heights, NJ, US, 07922
Nearest Major Market: New Jersey
