Title: Director, Regulatory and Contracts Counsel
Location: Edison, NJ/Remote
If you are interested in the below position, please send your resume to firstname.lastname@example.org and REFERENCE THE POSITION TITLE AND REGION within the subject line.
The Director, Regulatory and Contracts Counsel will be responsible for providing timely, practical, and high-quality legal advice on (i) tactics and strategies undertaken by the Company’s Commercial and Medical Affairs teams and (ii) a range of company contracts, including clinical trial and commercial contracts. This role reports to the General Counsel.
Responsibilities include but are not limited to:
––Partnering with commercial, regulatory, and medical colleagues to ensure timely review of promotional materials and medical affairs communications
––Reviewing clinical trial agreements and contracts in support of the Commercial and Medical Affairs teams, including consulting agreements, speaker agreements, advisory board agreements, and certain vendor services agreements
––Leading and coordinating enhancements to the Company’s contracting process
––Evaluating developments in the evolving legal and regulatory environment and the potential impact on the strategies of the Company
––Partnering with Compliance to identify and manage potential compliance risks and ensure compliance with corporate policies and procedures and applicable laws
–– 5+ years of pharmaceutical/biotechnology experience, with experience working on regulatory and/or litigation matters for pharmaceutical products and/or contracting for pharmaceutical or biotechnology companies
–– Experience in hematology preferred but not required
–– Strong understanding of the legal and regulatory environment in which pharmaceutical/biotechnology companies operate (e.g., anti-kickback and fraud and abuse laws and the regulatory framework governing prescription products)
–– Demonstrates a strategic approach to providing legal advice, keeping in mind the company’s goals and objectives
–– Excellent interpersonal skills with the ability to provide legal advice in a clear, concise and constructive manner in a fast-paced environment.
–– Highly effective written and verbal communication skills
–– Strong organizational skills
–– Ability to anticipate and solve problems
–– Strong work ethic with an ability to adapt quickly