IP Litigator

This a Full Remote job, the offer isavailable from : EMEA The position is for an IP and Regulatoryexclusivity (Pharmaceutical Incentives) senior lawyer. The positionincludes providing advice, assistance and leadership on regulatoryissues which are integral part of the exclusivity position of aproduct, in particular regarding regulatory exclusivities,developing strategies that will create synergies with IPexclusivities to optimize life cycle management (LCM), the optimalcreation of exclusivities for development / pipeline products and theloss of exclusivity (LoE) position of CSL’s products.This IP lawyer will coordinate complex regulatory exclusivity andother related activities , e.g. LoE strategies, taking into accountthe IP landscape and broader political and commercial environment.This position reports to the head of IP and is a member of theenterprise global IP leadership team. The Role

• Beup-to-date with Regulatory and Pharmaceutical Incentiveslegislations in EU and new regulatory developments globally toensure proper implementation across the global IP organization
• Support the global IP organization with respect to theimplementation of the new EU Pharma legislation package and EUtransparency rules
• Design and support implementation oflife cycle management (LCM) strategies and loss of exclusivity(LoE) strategies with a focus on the regulatory exclusivity aspectsin collaboration with IP team member(s) and business partners
• Design and support periodic exclusivity reviews to ourpipeline / development products to maximize the length and strengthof regulatory and IP exclusivities
• Advise on patentlitigations strategies with an emphasize of regulatory exclusivitylinkage
• Ensure the global IP organization takesconsistent approaches towards life cycle management (LCM)strategies and loss of exclusivity (LoE) strategies.
• Design and coordinate implementation of collaboration streams withGlobal Regulatory and R&D to secure / maximize value creation(Patent Term Extensions, Patent Linkage, Paediatric Extension,review of critical registration dossier sections)
• Guidepatent drafting and prosecution on the basis of regulatory andpharmacovigilance innovation such as risk management plans, sideeffects and percations;
• Build a LCM / LoE functional teamthat works together on challenging problems and provides mutualsupport.
• Conceive and execute RoW IP litigationstrategies in collaboration with other team members
• Directly manage certain RoW IP disputes or PharmaceuticalIncentives disputes
• Negotiate settlements and licenseagreements
• Advise RoW business partners regarding IPstrategy and litigation risk
• Build RoW IP litigationfunctional team that works together on challenging problems andprovides mutual support
• Support professional developmentof functional RoW IP litigation team members, including throughmentoring, coaching, continuing legal education, and sharing ofbest practices
• Ensure RoW IP litigation team takesconsistent approaches towards handling cases
• Managegovernance and reporting of RoW IP litigation
• Manage RoWIP litigation budget
• Monetize IP assets via licensingand, if necessary, patent enforcement
• Collaborateeffectively across functions with multiplestakeholders