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Job Summary:
The Intellectual Property (IP) will oversee all legal aspects related to patents, trademarks, copyrights, and trade secrets within the pharmaceutical sector. This role requires an individual with executive presence and strong patent & IP legal skills combined with a hands-on work ethic. The role requires expertise in patent law, FDA regulations, and pharmaceutical intellectual property protection.
Job Details
Description
Job Summary:
The Intellectual Property (IP) will oversee all legal aspects related to patents, trademarks, copyrights, and trade secrets within the pharmaceutical sector. This role requires an individual with executive presence and strong patent & IP legal skills combined with a hands-on work ethic. The role requires expertise in patent law, FDA regulations, and pharmaceutical intellectual property protection.
Must have the ability to work seamlessly in a cross-functional business environment, be highly innovative and be well-versed in pharmaceutical new product development processes, patent procurement, enforcement and monetization while staying aligned with the overall business strategy. An experienced patent practitioner with formulation development experience and a high-level of sophisticated judgment on patent matters and an ability to think strategically while managing through ambiguity to develop pragmatic solutions. Will be a team player who can build strong professional relationships with the pharmaceutical development team, corporate legal, senior executives, external counsel and colleagues at all levels across the organization.
Responsibilities
- Examines patents, file histories, prior art, ongoing litigations, and citizen’s petitions to inform related strategies for the development of 505(b)(1) and 505(b)(2) product applications and/or potential product acquisitions.
- Assists in assessing and guiding formulation development in view of patents and potential future strategic litigation (Hatch-Waxman inclusive).
- Secures freedom-to-operate and patent analyses for in-house products and potential product or technology acquisitions.
- Assists R&D in the assessment of patents relating to bulk API, route of synthesis, finished dosage forms and polymorphs.
- Designs and manages prior art searches for targeted technologies or products.
- Partners with legal and regulatory affairs for the preparation of Orange Book listings and patent certifications along with the corresponding notice letters and detailed statements
- Drafts and file global patent applications and secures patent rights for same.
- Provide legal counsel on trademark protection, copyrights, and trade secrets.
- Oversee patent litigation and disputes.
- Monitor legislative changes affecting pharmaceutical intellectual property.
- A Juris Doctor from a recognized, accredited law school is required.
- Minimum of a Masters’ Degree in Pharmaceutics, Chemistry, Biochemistry, or similar discipline.
- Minimum of 10 years’ experience, preferably a combination of private and corporate practices, and including Hatch-Waxman experience.
- 5+ years of experience in patent and intellectual property law, preferably in the pharmaceutical sector.
- Strong knowledge of patent prosecution, FDA regulations, and IP litigation.
- Excellent negotiation, communication, and analytical skills.
As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
LegalIndustries
Pharmaceutical Manufacturing
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