ROW IP Litigator and Regulatory Exclusivity Expert

vor 1 Tag

Bern, Schweiz TN Switzerland Vollzeit
ROW IP Litigator and Regulatory Exclusivity Expert, BernClient:

CSL

Location:

Bern

Job Category:

Other

Job Reference:

2a01f526aab1

Job Views:

9

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

The position is for an IP and Regulatory exclusivity (Pharmaceutical Incentives) senior lawyer. The position includes providing advice, assistance, and leadership on regulatory issues which are integral to the exclusivity position of a product, particularly regarding regulatory exclusivities, developing strategies that will create synergies with IP exclusivities to optimize life cycle management (LCM), the optimal creation of exclusivities for development/pipeline products, and the loss of exclusivity (LoE) position of CSL’s products.

This IP lawyer will coordinate complex regulatory exclusivity and other related activities, e.g., LoE strategies, taking into account the IP landscape and broader political and commercial environment.

This position reports to the head of IP and is a member of the enterprise global IP leadership team.

The Role

  1. Be up-to-date with Regulatory and Pharmaceutical Incentives legislations in EU and new regulatory developments globally to ensure proper implementation across the global IP organization.
  2. Support the global IP organization with respect to the implementation of the new EU Pharma legislation package and EU transparency rules.
  3. Design and support implementation of life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies with a focus on the regulatory exclusivity aspects in collaboration with IP team member(s) and business partners.
  4. Design and support periodic exclusivity reviews to our pipeline/development products to maximize the length and strength of regulatory and IP exclusivities.
  5. Advise on patent litigations strategies with an emphasis on regulatory exclusivity linkage.
  6. Ensure the global IP organization takes consistent approaches towards life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies.
  7. Design and coordinate implementation of collaboration streams with Global Regulatory and R&D to secure/maximize value creation (Patent Term Extensions, Patent Linkage, Pediatric Extension, review of critical registration dossier sections).
  8. Guide patent drafting and prosecution based on regulatory and pharmacovigilance innovation such as risk management plans, side effects, and precautions.
  9. Build a LCM/LoE functional team that works together on challenging problems and provides mutual support.
  10. Conceive and execute RoW IP litigation strategies in collaboration with other team members.
  11. Directly manage certain RoW IP disputes or Pharmaceutical Incentives disputes.
  12. Negotiate settlements and license agreements.
  13. Advise RoW business partners regarding IP strategy and litigation risk.
  14. Build RoW IP litigation functional team that works together on challenging problems and provides mutual support.
  15. Support professional development of functional RoW IP litigation team members, including through mentoring, coaching, continuing legal education, and sharing of best practices.
  16. Ensure RoW IP litigation team takes consistent approaches towards handling cases.
  17. Manage governance and reporting of RoW IP litigation.
  18. Manage RoW IP litigation budget.
  19. Monetize IP assets via licensing and, if necessary, patent enforcement.
  20. Collaborate effectively across functions with multiple stakeholders.

Skills and Experience

  1. At least 15+ years ex-US IP litigation experience with focus on biologics IP litigation (brand on brand or biosimilar).
  2. At least 10+ years experience in life cycle management and loss of exclusivity strategizing.
  3. At least 10+ years experience in handling complex IP incentives and regulatory strategies or disputes.
  4. At least 10+ years experience litigating and resolving IP and regulatory exclusivity related contract disputes.
  5. At least 10+ years experience monetizing IP assets.
  6. Experience leading a team of in-house IP lawyers.
  7. Excellent understanding of IP, Pharmaceutical Incentives, and associated regulatory legislation.
  8. Strong experience in developing and implementing life cycle management and loss of exclusivity strategies.
  9. Demonstrated ability to achieve optimal results in IP litigation cases; experience in Pharmaceutical Incentives/Regulatory exclusivity disputes is an advantage.
  10. Ability to solve complex and challenging problems.
  11. Practical and creative mindset.
  12. Demonstrated business acumen and ability to deliver useful advice.
  13. Superior verbal and written communication skills and ability to communicate complex concepts to business partners in an understandable way.
  14. Sound judgment.
  15. Strong interpersonal and team player skills and the ability to effectively interact with people from diverse backgrounds.
  16. Ability to prioritize and effectively handle multiple projects at the same time.
  17. Comfortable working on teams and independently.
  18. Agile learner capable of stepping quickly into new situations.
  19. Leadership competencies, including strategic thinking, building and optimizing teams, and developing, mentoring, and coaching team members.

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the well-being of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life.

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.

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