Associate Director, Counsel Global Clinical Development

Recruiter
Regeneron Pharmaceuticals
Location
Tarrytown
Salary
Competitive
Posted
Jul 17, 2017
Closes
Jul 18, 2017
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary

As part of the Pharmaceutical Legal Operations Department, this attorney will provide legal support to the Global Clinical Development teams supporting Regeneron?s robust clinical pipeline. The Associate Director will be responsible for providing advice and counsel on a wide range of legal and regulatory issues related to drug discovery and development. The attorney will serve as a proactive, solutions-oriented ethical counselor to internal Regeneron clients. The ideal candidate will have knowledge of the Food, Drug & Cosmetic Act as well as other laws and regulations impacting the healthcare industry. Experience with the False Claims Act, Anti-Kickback Statute required. Knowledge of privacy laws, ICH GCP and FDA regulations relating to clinical trials a plus.

Responsibilities

? Provides advice and counsel to clinical teams accountable for day-to-day management and operations of clinical studies across various therapeutic areas

? Partner with Regulatory and Pharmacovigilance teams to ensure compliance with laws and regulations

? Provide legal support to teams handling GCP non-compliance investigations

? Serve as a subject matter expert on clinical matters within the Law Department and collaborate with other legal functions (e.g., Business Development and Contracting, Compliance, Litigation and Products/Regulatory Law group)

? Conduct training to client groups on a variety of legal and regulatory issues

Requirements

BA/BS and JD with excellent law school credentials

Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel

5+ years experience; biotech/pharmaceutical experience required. In-house experience a plus but not required.

Essential Skills and Abilities

? Exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution.

? Excellent negotiation skills requiring strong interpersonal communication and oral and written communication skills.

? Willingness to learn, adapt and grow with a highly successful science-based biotech

? Ability to persuade with verbal and written communications involving multiple key client groups.

? Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations.

? Ability to work independently on projects, set and meet aggressive deadlines, and juggle multiple matters.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron?s unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.