Senior Counsel, Branded Products

Zydus Pharmaceuticals (USA) Inc. is seeking a candidate with five-plus years experience in the life sciences and pharmaceutical industry with a specialized knowledge of late-stage development and commercialization. The Senior Counsel will be an integral member of the Zydus legal team and will serve as the legal advisor for the company?s specialty, brand and generic products. The Senior Counsel will be responsible for market access and customer-facing contracting, serve as a member of the promotional materials review committee and the medical legal review board and will provide other legal support as needed. The position will report directly to VP, General Counsel. This exciting opening offers the candidate the opportunity to be a part of a professional, customer-focused, pharmaceutical company with a competitive salary and full benefits package.

Zydus Pharmaceuticals (USA) Inc. is a globally integrated pharmaceutical company with a focus on providing high service, quality, and affordable products. Our US leadership, which has over 60 years of US generic market experience, understands the customer?s business which allows Zydus the ability to provide unique models to help drive their customer?s success. Our parent company, Zydus Cadila, has a large presence in global markets, including relationships with many top tier international pharmaceutical companies. Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India.

RESPONSIBILITIES:

• Draft and negotiate agreements for the clinical operations organization; including but not limited to, clinical trial agreements, master services agreements and research agreements.
• Negotiate, draft, and review market access and customer-facing contracts including product purchase, supply, distribution, PBM, GPO, wholesaler/distribution, rebate/discount, and specialty pharmacy agreements. Provide legal guidance on contracting and strategy for established and newly launched products.
• Advise on a broad array of issues relating to the marketing and promotion of pharmaceutical products. Represent the legal department on internal committees to review materials related to disease awareness, patient education, patient access, patient support, press releases, interactions with HCP and payers to ensure that materials and strategies are compliant with legal and regulatory requirements as well as with internal company policies.
• Negotiate, draft, review general commercial and other contracts including HCP consultant and speaker agreements, vendor and service provider MSAs and SOWs, and liaise with internal clients and Legal colleagues to finalize same.
• Counsel on FDCA and other applicable laws and regulations, including federal and state anti-kickback statutes, FCA, FCPA, FDA regulations, OIG guidance, PhRMA Code, Federal healthcare programs, state drug transparency laws, HIPAA/privacy.

QUALIFICATIONS ? SKILLS & REQUIREMENTS:

• Ability to analyze and solve problems and provide timely and practical advice and solutions
• Ability to identify and analyze legal issues and risks, with the ability to provide well-reasoned and business-focused advice to internal business units
• Possess a solid understanding of drug pricing and reimbursement in the US marketplace as well as patient support programs
• Outstanding interpersonal and communication skills
• Strong organization and teamwork skills. Detail-oriented, self-motivated and able to motivate others
• Unwavering commitment to ethics and integrity

EDUCATION & EXPERIENCE:

• J.D. degree and admission to a state bar in any jurisdiction (preferably NJ)
• At least 5 years experience in the branded pharmaceutical industry
• Preference for applicants with experience in launching products

TRAVEL:

• Position may require limited domestic travel (less than 5%).

WORK ENVIRONMENT:

This is an office-based position, located in our office in Pennington, NJ. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is:

• Frequently required to sit and/or stand, walk, talk, and hear.
• Ability to sit at a computer for an extended period of time.
• Vision ability requirements include clarity of visions at 20 inches or less due to computer work.
• Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic).
• Constantly required to use hands and fingers to operate office machines and equipment.
• Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch.

The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job.