Donise Winter

Background

About Donise Winter

Core Competencies: Pharma/Biotech lawyer 25+ Years' PQE (industry and private practice). IP/ Competition Law / Transactions/ Corporate Governance background. Pharma/Biotech Lawyer with broad-ranging industry legal experience: •Strong track record of legal and transactional support of R&D activities, IP Licensing, Collaborations & Global Business Development activities. •Global antitrust and competition law advice, including planning and implementing complex transactions and long-term collaborations to achieve commercial objectives in compliance with competition laws and managing clearances. •Strategic and operational commercial legal support at global, regional and local affiliate level. •Strong reputation for partnering with business colleagues, adding value to business decisions and enabling business strategies, guided by effective risk management. •Implementation of effective compliance tools, to constructively advise and guide business teams on legal issues that may impact commercial success or create compliance risks (incl. healthcare compliance, FCPA/Bribery Act, data privacy, antitrust and competition laws). •Implementing contract management systems. •Partnering on global pricing governance and providing legal support to global, regional and local business/market access colleagues to develop compliant pricing strategies across regions/countries, maintain value and enable broad access to medicines (including sustainable access in LLMICs). •Design and implementation of compliant and effective supply and distribution systems. •Regulatory law advice on GxP, global clinical trials management and regulatory compliance. •Strong track record of successfully managing audits, investigations and litigation, including strategic management of response and interfacing with regulators and opposing parties.