IP & Litigation Counsel, Pharma | Hatch-Waxman Expert

Hikma Pharmaceuticals; Berkeley Heights (NJ); On-site; USD 121,000 - 221,000; Full time

Job summary

Hikma Pharmaceuticals in Berkeley Heights, NJ seeks a Counsel, IP and Litigation to provide strategic and day-to-day IP and litigation support for our North American injectables and non-injectables business. You will work with R&D on product development, protect trademarks and patents, secure regulatory approvals and support launches.

The role includes managing outside counsel, handling IP due diligence for BD deals, and guiding regulatory strategies for 505(b)(2) and ANDA products.

Qualifications

• Juris Doctor from ABA-accredited school and admission to practice in the U.S.
• Preference for USPTO registration or ability to qualify for it.
• 7+ years in pharma or life sciences IP and litigation, preferably with a top firm.
• Experience with Hatch-Waxman and the BPCIA and related regulations.
• In-house experience with a global pharmaceutical company is desirable.
• Strong analytical, drafting and oral/written communication skills.
• Ability to lead cross-functional teams in a fast-paced environment.

Responsibilities

• Manage US patent strategies for injectables and non-injectables API selection and product development through launch.
• Coordinate with R&D, regulatory, commercial and management teams to provide IP and legal counsel on Hatch-Waxman timing for approvals and launches.
• Oversee outside counsel and patent litigation, including discovery, expert retention, and strategy.
• Advise management on litigation strategy, settlements and launch scenarios.
• Manage general litigation matters: contracts, products liability, employment, and other disputes from discovery through trial and appeal.
• Assist in regulatory strategies for new products including 505(b)(2) and ANDA products.
• Provide IP due diligence on BD, licensing, co-development, and M&A deals and coordinate IP input in business development.

Skills

IP strategy

Litigation management

Hatch-Waxman Act

BPCIA knowledge

Regulatory affairs

Education

Juris Doctor (JD)

Tools

USPTO registration

Job description

Hikma Pharmaceuticals in Berkeley Heights, NJ seeks a Counsel, IP and Litigation to provide strategic and day-to-day IP and litigation support for our North American injectables and non-injectables business. You will work with R&D on product development, protect trademarks and patents, secure regulatory approvals and support launches.

The role includes managing outside counsel, handling IP due diligence for BD deals, and guiding regulatory strategies for 505(b)(2) and ANDA products.