Director, Senior Counsel

Job content

The Director, Senior Counsel will be responsible for providing legal support to German, Austrian and other European colleagues in Commercial, Market Access, Medical Affairs and other departments, including supporting the planned launches of new pharmaceutical products. The position requires native-level German language skills and fluency in English. The ideal candidate will have prior experience counseling prescription drug companies on legal issues in Germany, Austria and other European countries relating to the launch of new pharmaceutical products, marketing, promotion, advertising,scientific exchange, and interactions with health care professionals.

Tasks

• Advise German, Austrian and other European colleagues on various commercial, medical and clinical development initiatives in a way that advances the Company’s strategy while addressing legal risks and protecting the Company’s integrity and reputation.
• Provide local and regional legal advice on promotion, market access, pricing and reimbursement, the use of social media; dissemination of scientific information, product liability, competition, and other matters relevant to the development, regulatory approval, and commercialization of prescription drugs.
• Act as a subject matter expert on matters relating toGerman, Austrian and European healthcare laws and related business operations and stay abreast of evolving local healthcare legislation andregulations.
• Proven experience in developing local policies, procedures and processes for Germany, Austria and other European countries adapted from regional and global SOPs that help the business to comply with local laws, regulations and codes and drive for consistency.
• Ability to work autonomously with high mental agility, including the ability to prioritize workload and operate within a fast-paced business environment.
• Ability to build relationships and influence at all levels, demonstrating a flexible approach to connect with colleagues in the broader organization and engage with multiple stakeholders to driveprojects and cultural change.
• Ability to identify legal and compliance risks and provide timely and appropriate advice and action in response.
• Draft, negotiate and manage a high volume and wide variety of contracts, including confidentiality, consulting, services, research, supply, material transfer agreements, distribution and clinical trial agreements.
• Provide practical, solution-oriented legal support to internal clients during contract preparation and negotiation.
• Train and educate internal local and regional clients on the use of contract templates, relevant legal issues, and good contracting practices.
• Analyze, review and approve promotional and educational materials.
• Analyze, reviewand approve scientific exchange and clinical support approaches.
• Provide guidance on proposed localsales and marketing strategies.
• Review and counsel on government enforcement actions relating to the promotion of pharmaceutical products.
• Ability to manage external counsel, building effective relationships and monitor legal spend.
• Excellent verbal and written communication skills and the ability to develop and provide clear direction to the business and pragmatic solutions to complex legal & compliance challenges.
• Sound judgment, combined with the self-confidence and gravitas to identify, assess and control legal and compliance risk and deliver recommendations and effective advice on diverse legal and business matters.
• Generate reports, presentations, spreadsheets, memos and other documents for the Legal and Compliance Department, internal/ external clients and/or the senior management team,as requested.
• Complete special projects/responsibilities as requested.
  

Requirements

• Native-level fluency in German and fluency in English required. Additional European language skills are and advantage.
• Experience advising on and strong and up to date knowledge of German,Austrianand other European medicines/ biopharmaceuticals laws, regulations, codes of practice and best practices.
• Demonstrated experience gained within the pharmaceutical or biotechnology industry and/or significant law firm experience advising clients within the life sciences sector, including with thelaunch of new pharmaceutical products.
• A demonstrated ability to collaborate, as well as to work independently, balancing competing priorities in a fast-paced, deadline-driven environment with a high level of professionalism.
• Highly effective communication skills (both verbal and written).
• Excellent drafting, negotiation, communication, analytical and problem-solving skills.
• Ability to meet deadlines and work across time zones.
• Detail-oriented.
• Ability to handle confidential and proprietary information using discretion and judgment.
• Self-motivated, able to work independently and be reliable and responsive.
• Ability to be flexible and willing to accept new responsibilities as needed.