Location: Berkeley Heights NJ
Job Type: Full-Time
About 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. 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:
To perform this job successfully, an individual must be able to perform each
essential duty satisfactorily:
* 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.
* 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.
Compensation:
Base Salary: $121,350.00 - $220,850.00 annually. The compensation for this
position will be determined during the interview process and will vary based on
multiple factors, including, but not limited to, work location, prior experience
and job-related knowledge, relevant skills and expertise, current business
needs, and market factors. The Talent Acquisition team can provide more details
about the specific salary range for the job location during the hiring process.
What We Offer*:
* Annual performance bonus, commission, and share potential
* Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution
rate of 3% of eligible pay. Hikma will match 100% of the first 6% of
eligible pay that you contribute
* A generous paid time off (PTO) bank starting with 20 days (prorated based on
hire date). Additional days granted upon reaching work milestone
anniversaries
* 3 personal days (prorated based on hire date)
* 11 company paid holidays
* Comprehensive benefits including health, dental, vision, mental health,
disability, life insurance, prescription drug coverage, and a variety of
voluntary benefits
* Employee discount program
* Wellbeing rewards program
* Safety and Quality is a top organizational priority
* Career advancement and growth opportunities
* Tuition reimbursement
* 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.
Equal Opportunity Employer:
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.
Agency Notice:
Please note that Hikma has a set roster of approved recruiters for specific
roles agreed to in advance and does not accept unsolicited resumes or calls from
third-party recruiters or employment agencies regarding open positions. In the
absence of a signed agreement and approval from Hikma’s Human Resources
department to submit resumes for a specific
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