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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Biotechnology
Pharmacology
5-7 yrs required
Assoc. Director, Assistant General Counsel The candidate will provide legal expertise and support across all business functions within the company. Oversee and manage the contracting function for all business departments within the Company, including, but not limited to: Advising all business departments within the Company regarding FDA regulatory matters and compliance with laws, regulations, industry standards and Company policies that may arise throughout the Product lifecycle. Providing legal counsel on health care laws, including the Federal Anti-Kickback Statute, False Claims Act and related health care legal obligations. Providing legal advice and business counsel on innovative marketing and sales strategies, activities and programs. Providing and coordinating legal support to cross-functional teams supporting the business. Working closely with other Legal Department colleagues and Compliance professionals to provide consistent and efficient legal and compliance support to the Company in accordance with company’s healthcare compliance policies and related laws, codes and regulations. Work closely with cross-functional teams including Clinical, Medical Affairs, Regulatory, Compliance, Finance, Procurement, Tax and other business functions to facilitate consistent and efficient support for clinical trials. Other ad hoc analysis / projects as deemed appropriate.
Qualification and Experience
The candidate should have a Juris Doctorate degree from Accredited Law School. Admission to the N.Y. or N.J. State Bar or eligible to obtain a N.J. limited license for in-house counsel. Minimum 5-7 years of major law firm or in-house experience, with a minimum of 3 years as in-house counsel or in a law firm representing pharmaceutical and/or biotech companies. Demonstrated strong understanding of the U.S. and EU Legal requirements related to the pharmaceutical industry. Strong grasp of relevant federal and state laws, regulations, rules and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, focused on drug labeling, drug advertising, fraud and abuse (anti-kickback, off-label promotion), product liability, etc. Knowledge of enforcement landscape, including relevant industry investigations, litigation and settlements. Experience drafting and negotiating contracts such as master service agreements, statements of work, confidentiality agreements, supply agreements, consulting agreements, and other corporate pharmaceutical-related agreements is required. Experience drafting and negotiating agreements such as clinical trial agreements, informed consent forms, confidentiality agreements, delegations of authority and other clinical research-related agreements is required. Knowledge of current laws, regulations and industry standards governing clinical trials, such as FDA regulations, ICH Guidelines, and GCPs is required. Must understand contract law and have strong communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions. Proven ability to interpret and apply legal requirements to specific projects and agreements. Proven knowledge of corporate legal issues, particular to the pharmaceutical and/or Biotech industry including contracts. Excellent written and verbal English communication skills. Demonstrated excellent organizational skills. Proven negotiation skills. Proven ability to manage multiple projects, set priorities and meet deadlines. Excellent skill level in MS Office including Word, Excel and Outlook.
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