Rhythm Pharmaceuticals, Inc. seeks an experienced and highly motivated individual to join its Legal and Compliance team and provide counsel within our International Region, with a particular focus on Europe.
As International Counsel, you will provide broad based legal and compliance support relating to Rhythm’s lead compound, setmelanotide, as well as provide legal and compliance support on issues relating to Rhythm’s development programs/pipelines generally. You will report to the Head of Legal of Rhythm’s International business, based in the UK.
Responsibilities and Duties
• Act as the legal counsel to internal clients on EMA/MHRA laws 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 advice and counsel to clients on EMA regulations and local country requirements with respect to product labeling, promotional activities, and marketing strategies.
• 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 global promotional materials through Rhythm’s Promotional Review Committee.
• Review, analyze, and advise on matters related to reimbursement activities, market access, patient support and assistance programs, government coding and reimbursement as well as 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.
• Provide legal advice and guidance on data privacy laws, regulations, best practices and participation in strategic planning and decision-making processes related to data privacy.
• Help to formulate Rhythm’s GDPR compliance plan, data privacy strategies, policies, and procedures ensuring that Rhythm’s data privacy policies and procedures are effectively managing privacy risk.
• Assist in developing, implementing, and enhancing the company’s compliance function, including establishing policies and procedures and 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.
• Develop and provide appropriate training.
• Manage outside counsel as needed in connection with executing above responsibilities and duties.
Qualifications and Skills
• 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.
• Substantial experience with drafting, reviewing, and negotiating the types of contracts relevant to the pharmaceutical/biotech industry (e.g., research, clinical, commercial, etc.).
• Experience in handling Data Privacy matters and general data issues in a commercial environment.
• Significant legal experience in Compliance.
• 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 through Rhythm’s Promotional Review Committee.
• Working knowledge/experience with GxP a plus.
• Excellent interpersonal communication and negotiation skills, including both oral and written communication skills.
• Ability to independently manage workload in a fast-paced environment. Ability to provide practical, timely, and risk-appropriate legal counsel to a wide variety of internal clients on legal and regulatory matters and interact effectively with employees at all levels of the organization.
• Fluent in speaking and writing in English.
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