Biopharma International Counsel - Data Privacy & Compliance

• Primary leadership for providing legal advice and guidance on data privacy laws, regulations, best practices, strategic planning, and decision-making processes related to data privacy.
• Help to advance Rhythm’s GDPR compliance plan, data privacy strategies, policies, and procedures ensuring that Rhythm’s activities are compliant with relevant laws and regulations, and effectively managing privacy risk.
• Work with the legal team and other departments to ensure company operations and products are compliant with data privacy laws, including overseeing data privacy-related issues, handling and data security incidents, and managing investigations and audits by regulatory bodies.
• Assist in developing, implementing, and enhancing the company’s compliance program with a focus on the International region, including establishing policies and procedures and developing and providing appropriate training.
• Act as the legal counsel to internal clients on EMA/MHRA laws and regulations, fraud and abuse laws and regulations and other relevant laws and regulations related to the development and commercialization of pharmaceutical products in the EU and international jurisdictions.
• Review and provide legal guidance on interactions with healthcare professionals, patients, payers, and advocacy groups to ensure compliance with applicable laws and regulations.
• Provide well-informed and practical advice and counsel to clients on EMA regulations and local country requirements with respect to product labeling, promotional activities, and marketing strategies.
• As a trusted business partner, advise colleagues in the International region with respect to projects, initiatives, and communications regarding approved products and indications as well as those pending market authorization.
• Review and provide guidance on promotional materials through membership on Rhythm’s Legal, Medical, and Regulatory (LMR) Committee.
• Review, analyze, and advise on matters related to reimbursement activities, market access, patient support and assistance programs, government coding and reimbursement, and payment and coverage decisions.
• Draft, review, and negotiate research-related contracts, clinical trial agreements, commercial contracts, 3rd party vendor agreements, service agreements, consulting agreements and other corporate agreements.
• Collaboratively partner with US-based Legal and Compliance colleagues to ensure consistency in approach across the global organization.
• Proactively identify legal and compliance risks and work with other internal stakeholders to effectively eliminate or mitigate those risks while concurrently supporting business strategic goals.
• Manage outside counsel as needed in connection with executing above responsibilities and duties.

• LL.M. Degree.
• Licensed to practice law in Europe with bar admission in at least one European country.
• 5+ years’ experience as a practicing attorney, with at least 3 years’ experience advising the pharmaceutical/biotech industry in and across Europe. In-house pharmaceutical/biotech industry experience a plus.
• Possess upwards of 4 years' experience in handling Data Privacy matters and general data issues in a commercial environment.
• Significant experience in Compliance.
• The preferred candidate will have worked at a leading European national law firm and/or had an in-house counsel position with a leading biotech/pharmaceutical company with significant marketed products preferred. Experience with rare disease products a plus.
• Strong experience with EU and international laws and regulations governing pharmaceutical/biotech products including understanding of applicable regulations and laws relating to the development, sales and marketing of pharmaceutical products, and the current government enforcement landscape. Experience with laws and regulations governing genetic testing a plus.
• Knowledge of EMA regulations and local country requirements with respect to promotional activities and marketing strategies and substantial experience in review and providing guidance on global promotional materials as part of a promotional review committee.
• Substantial experience with drafting, reviewing, and negotiating the types of contracts relevant to the pharmaceutical/biotech industry (e.g., research, clinical, commercial, etc.).
• Working knowledge/experience with GxP a plus.
• Fluent in speaking and writing in English.

Rhythm Pharmaceuticals