Director, Legal

Job Description
Supporting Legal, Business Development (Par and Strativa), Regulatory Affairs, Research & Development, and related functions through the provision of legal and technical advice pertaining to all intellectual property matters as well as attendant legal/technical matters in antitrust, regulatory affairs, R&D, and business.

Essential Duties and Responsibilities:
•Strategically developing pre-litigation and litigation strategy and supporting preparation pertaining to generic targets, generic pipeline products, and specialty branded products, including review of briefs, motions and reports prepared by external counsel as well as witness preparation.
•Strategically preparing, and supporting prosecution and registration strategy (including reexamination/opposition strategy) for all forms of intellectual property protecting product lines.
•Developing and preparing legal/regulatory strategy and approaches at the FDCA/21 CFR-IP interface including statute/rule interpretation as well as suitability and citizen’s petitions.
•Serving as a liaison between Business Development (Par and Strativa), Research & Development, Legal, Corporate Affairs, and Regulatory Affairs on the selection, protection, and development of generic and specialty branded pipeline products and attendant legal and technical implications.
•Supporting Business Development (Par and Strativa), Research & Development, Regulatory Affairs, Human Resources, and Legal with intellectual property and technical strategy and legal advice, germane to patents, trademarks, copyrights, trade secrets, confidential/proprietary information, non-compete agreements, FDCA, Hatch-Waxman, and the regulatory and antitrust implications pertaining thereto.
•Assisting in the preparation, review, and revision of contracts, internal policies and protocols, assignments, development/collaboration agreements, licenses, and the like on topics pertinent to intellectual property, including any and all confidential/proprietary information.
•Assisting Research & Development with formulation and technical development strategies.
•Identifying and analyzing, in view of the intellectual property and technical aspects of the products, potential generic and specialty branded pipeline targets and opportunities, including assisting in the development of lifecycle management opportunities for all product lines.
•Assisting, with the provision of legal and technical advice, Business Development with the selection of API sources.
•Providing intellectual property and technical due diligence on potential branded products, and generic collaboration/acquisition opportunities.
•Supporting the policing and the protection of trade secrets, confidential/proprietary information, and all forms of intellectual property.
•Reviewing and supporting the response to notices, orders, motions, subpoenas, and the like served on the company in view of intellectual property-related third party litigation.
•Strategically providing intellectual property and technical advice, and serving as a legal/technical liaison, to third party development/collaboration partners on generic and branded products/projects.

Education and or Experience:
•M.S., Pharm.D., M.D., Ph.D. or B.S. with significant research experience (chemistry, pharmacology, biology).
•Registration as a patent attorney with the United States Patent & Trademark Office.
•Admission to a state bar and eligibility to secure a NJ in-house counsel license absent admission to NJ.
•3-5 years experience at a law firm and/or in-house working in the area of pharmaceutical patents and IP.

Competencies:
To perform the job successfully, an individual should demonstrate the following competencies:
•Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
•Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations
•Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
•Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates substantively in meetings.
•Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Able to read and interpret written information.
•Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
•Ethics - Treats people with respect; Keeps commitments and confidences; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
•Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions

Company

Par Pharmaceuticals

Job Code

State or Province

New Jersey

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