Role can be located in the tri-state area or the Miami area.
The General Counsel will supervise and oversee the Legal Department, IP and Corporate Compliance function, ensuring an OIG compliant organization inclusive of the company’s IP portfolio including identifying IP issues, developing effective solutions to IP problems, and guiding the business on a variety of pharmaceutical technology platforms and related products (the relevant IP can include patentable inventions, trade secrets, know-how, trademarks, service marks, trade dress, designs, and copyrights). The General Counsel role provide strategic legal and business guidance to senior management and cross-functional teams, and to lead, guide and motivate both internal and parent company personnel, and outside counsel to build valuable IP portfolios in support of US and global business goals and objectives.Responsibilities:
- Actively in charge of patent filings and prosecution; Harvesting and protecting such inventions; Participating in the Patent Committee meetings, organized by the IP Department, where patent filings or drop decisions are taken; Advising on (and acting/participating as the case may be with other legal department members or other departments) (a) patent matters in contractual relationships (e.g., development, collaborative, and clinical agreements; licenses; acquisitions) as well as freedom to operate and due diligence analyses, (b) offensive/defensive IP litigation, and (c) the significance of intellectual property matters to promote awareness and innovation.
- Provide legal counsel and guidance to the officers and directors of Noven and advise them as to legislation and regulations which may affect business activities.
- Initiate legal action against corporate aggressors and with regard to improper or potentially adverse regulatory or governmental actions; defend Noven in any legal actions.
- In collaboration with intellectual property counsel, initiate and defend legal actions protecting the value of Noven intellectual property, including Paragraph IV litigations and Inter Partes Reviews.
- Provide oversight and leadership to the intellectual property counsel in the development and management of Noven’s patent and intellectual property portfolio.
- In collaboration with Business Development, provide leadership to the company and to its business partners and potential business partners in achieving operational and relationship objectives and increase the likelihood of success of the partnership. Review, prepare, and negotiate documents in connection with corporate acquisitions and divestitures, mergers and strategic alliances, license arrangements, purchases or sales of securities and other assets of corporations and the contents of purchase or sale contracts, merger agreements, or other business arrangements; prepare and make appropriate filings and obtain appropriate regulatory approvals with respect thereto.
- Select, retain, supervise, and coordinate outside counsel to defend or represent Noven or an employee or officer, if appropriate, in any administrative or other proceeding involving equal employment opportunity, unemployment compensation or other employment related legal matters.
- Assist in the definition and development of corporate strategies, policies, procedures, and programs.
- Evaluate the legal risks to which Noven may be exposed to allow these risks to be accurately reflected in financial statements.
- Primary responsibility for review and revision of contracts and statements of work with Noven vendors and certain other business partners
- Prepare NDAs, services agreements, consulting agreements and other contracts
- Perform primary and/or assisting role as needed in due diligence reviews, contract drafting and other matters related to business development opportunities
- Key role in Legal Department support of other functional areas, particularly Human Resources support of labor & employment related matters
- Lead the management of ongoing litigation, including responding to discovery requests and implementation of litigation holds
- Head the compliance sub-department for the organization, with responsibility for sales force compliance, aggregate spend reporting, records retention, SOP policy review/revision, state drug waste disposal compliance and similar matters. Includes managerial responsibility over a compliance manager.
- As head of the Generic Core Development Team, provide leadership, direction and oversight to the research, evaluation, development, partnering and commercialization of all generic drug opportunities for the organization.
- Advise, as required, in connection with the preparation of documents required for meetings of the board of directors and board consents, liaise with outside advisors and shareholder on board governance issues, attend, take and maintain minutes of Board of Directors meetings and ensure compliance with applicable Delaware law.
- Ability to balance the legal issues of a project with the goals of the business through the demonstration of strong, pragmatic business acumen and the ability to recognize the business consequences of legal advice; Strong advocacy skills; Ability to function autonomously, yet understands necessity of advising management of work progress and any unusual situations; Managing multiple tasks simultaneously and effectively; Ability to work independently and efficiently under time pressures and deadlines in a fast-paced environment; Ability to work with cross-functional and international teams; Adaptable to changing environments; Strong interpersonal skills including ability to engender trust, respect and confidence; Excellent written and oral communication skills including the ability to communicate and interact effectively at all levels of the organization. To support the Essential Functions, the candidate should be knowledgeable in IP Experience:
- US / European Patent Law
- IP Asset Management
- IP Strategy
- IP Partnerships / Agreements
- High-Value Patent Creation
- Due Diligence
- Cross-Functional Leadership
- IP Litigation
- Hatch-Waxman Act; FDA & Regulatory Exclusivity Options
- Clinical Studies and Contracts
- US Trademark & Copyright Law
Education & Experience:
- JD. and admission to state bar (Florida preferred).
- Complex negotiated transaction experience in the corporate department of a highly rated law firm or in-house legal department. Experience with pharmaceutical transactions.
- Outstanding written and verbal communication skills
- Outstanding leadership and management skills
- Knowledge of federal agencies including the FDA
- Strong work ethic, positive attitude, self-motivated and professional demeanor
- Ability to perform multiple tasks efficiently and accurately.
- Juris Doctor degree from an accredited U.S. law school and at least 10 - 12 years of professional experience as an attorney, including both law firm and in-house experience, with significant experience advising companies in the pharmaceutical sector.
- Majority of time spent in office environment, operating computer.
- Visual acuity and manual dexterity required to operate computer and proofread documents
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