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Years of Experience
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ProfileSenior Director, Regional Compliance Officer (EU) Responsibilities: Contribute to defining the regional and site compliance strategy to support the business by using a risk based approach to assessing business impact. Oversee, implement and administer (within the region/ site) Clovis’ corporate compliance programs & policies and International compliance standards & procedures. Lead/support risk assessment, investigation, monitoring & audit activities in the region/ site. Identify the need for specific local compliance procedures, leading their development and implementation. Lead (and in coordination with relevant functions) audit corrective action implementation and Monitoring/CSA related improvement action implementation. Understand compliance and business drivers, goals and strategy and be an advocate for Compliance within the business. Act as the contact point for healthcare compliance advice within the site/ region. Interact with and successfully influence all levels of staff in the region/ site to accomplish compliance initiatives and goals. Manage the relationship with external translation agencies or trainers. Balance physical presence and amount of time dedicated to each country according to regional and site priorities. Act as key contact for EU/EMEA regional compliance. Key Activities Provide leadership, advice, guidance, direction and support to office, field based staff and applicable third parties on interpretation and implementation of the local Code of Practice & legislation and Clovis healthcare compliance policies, procedures and practices. Maintain awareness of applicable laws and regulations affecting the site/ region and keep current with changes that may affect Clovis’ compliance program. Participate in and monitor changes at local Trade Association/ local Code Association & in national legislation. Forward relevant information to local teams and regional groups with recommended changes to compliance framework or strategy. Support the implementation of corporate and EU/EMEA compliance programs in the site/ region. Conduct local compliance monitoring activities and follow up on improvement actions. Participate in the compliance audit preparation: set up meetings with each department, prepare documentation request, facilitate audit and follow up on audit outcomes. Support corporate compliance communication strategies and participate in the development of specific communication strategies that will maximize awareness, trust and compliance with Clovis’ business practices, policies and procedures. Lead/participate in compliance initiatives/projects/expert review team for EU/EMEA compliance. Review, translate (if applicable), provide comments and implement EU/EMEA Healthcare Compliance procedures and training. Evaluate the need for, develop and ensure implementation of defined local compliance procedures. Develop training programs and materials for the local Code and Clovis local compliance procedures and projects. Coordinate, perform and track compliance training. Customize (and if applicable translate) Healthcare Compliance presentations and communications to local audience. Conduct EU/EMEA compliance monitoring activities. Review (& if applicable approve) local healthcare compliance activities in accordance with local SOPs and the local Code. Participate in regional compliance initiatives or projects if required. Serve as the country Data Privacy Officer. Provide legal support and substantive advice to sales, marketing, and market access departments concerning a broad range of legal, regulatory, and compliance issues. Prepare, review, and negotiate a wide variety of contracts in support of the commercial organization, including consulting, speaker, distribution, vendor, services and other agreements associated with commercial operations. Analyze product promotional initiatives for fraud and abuse, anti-kickback considerations, and general compliance. Participate in the on-going development, implementation, and management of Clovis Oncology’s compliance program. Develop compliance training materials for client functions, and conduct training presentations. Conduct routine and ad hoc compliance audits of functional areas to ensure adherence to laws, regulations, and company compliance policies and procedures. Develop a thorough understanding of and familiarity with Clovis Oncology’s business, its people, products, markets, customers and competitors in order to provide sound advice to supported client areas. Monitor changes in laws that affect client areas and share best practices.
Qualification and Experience
Qualifications: JD degree from an accredited law school. Excellent academic and law firm credentials. 5-7 years relevant prior experience at a law firm with an internationally recognized Life Sciences practice or in-house at a pharma/biotech organization. 2-3 years compliance related experience preferred 2-3 years in development function preferred Must be licensed to practice law in at least one (1) EU jurisdiction and in good standing. Fluency in English; proficiency in additional languages preferred (German/French/Spanish). Experience defining and implementing policies, procedures and SOP’s, and developing training materials is required. Experience working with cross-functional teams is necessary. Experience drafting and negotiating a wide variety of pharma-related commercial agreements. Excellent skills in verbal and written communication, with ability to distill complex legal issues to essential elements for clients throughout the organization with different abilities and responsibilities. Strong business acumen with exceptional judgment, particularly in determining the significance of legal matters and effectively measuring and managing risks. Strong organizational skills in order to prioritize and manage multiple time-sensitive projects simultaneously; willingness to assume heavy workload to meet timing and project needs. Ability to work in a team as well as independently. Proficiency in MS Office suite. Knowledge about applicable laws and regulations. Expertise in EMA and IFPMA regulations Foreign Corrupt Practices Act and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, government reimbursement, and interactions with healthcare professionals, and an ability to interpret and apply such laws, regulations and policies in the context of complex and novel business activities and situations.