Executive Director (m/f/d), Legal & Compliance - DACH Cluster (Germany, Austria, Switzerland) (m/f/d)

Executive Legal Director DACH Job Description

The Executive Director (m/f/d) and Head of Legal & Compliance for Germany, Austria and Switzerland (DACH) leads a team of legal & compliance professionals providing legal and compliance oversight over all aspects of the the Company's businesses in the DACH markets, including legal and compliance support to the Human Health and Animal Health businesses and across divisions, including commercial, medical, research and manufacturing. The primary responsibilities of the Executive Director and Head of Legal & Compliance for DACH will be to provide legal and compliance advice, protect the legal interests and uphold the ethical business standards of all the Company's businesses and divisions in the Company for the DACH markets.

In addition, the Executive Director and Head of Legal & Compliance for DACH serves as a member of the German Human Health Leadership Team and works in conjunction with business and functional stakeholders, team members across the global legal and compliance department, external counsel and relevant headquarters and subsidiary staff and functional groups, as needed. The position will be based in Munich, Germany and reports to the Regional Managing Counsel for the Core European Region.

Qualified applicants are excellent business lawyers, with outstanding people skills, including the ability to negotiate with third parties, and to work with internal stakeholders to shape and implement critical projects, and take a strong interest in understanding and implementing the Company's compliance standards by collaborating with the Business Practices organization in managing compliance issues across all divisions. The successful candidate will guide management on critical legal and compliance matters, and find pragmatic, legally-sound solutions on a wide array of commercial projects.

As a member of the CER Legal & Compliance Team, the successful candidate will also provide legal and compliance support on certain regional projects and liaise and collaborate with the Company's attorneys and compliance professionals throughout the world.

Main Responsibilities

Activities include, but are not limited to:

Management and Supervision:

• Responsible for guiding, monitoring and assisting with all activities across the business that require legal or compliance input and ensuring that the appropriate legal/compliance objectives and goals are met, and sound, appropriate and quality advice and oversight is given to business stakeholders by the Legal and Compliance team and external legal resources.
• Managing, leading and developing the DACH Legal & Compliance team.
• Assessing, supervising and managing the engagement of external legal resources and ensuring that the service and advice received from external legal resources is timely, cost-effective and of consistently high quality.
• Managing the legal budget for DACH in accordance with approved guidance from regional/global Legal and Compliance management.

Legal Matters:

• Providing legal guidance on all commercial activities, including market access and policy initiatives and commercial and business development transactions.
• Drafting and negotiating commercial agreements.
• Advising on commercial/corporate and labour issues and negotiating with external parties on behalf of the Company.
• Advising on competition law and helping to shape pro-competitive programs and offerings.
• Providing and/or overseeing internal legal review as part of the Company's medical/legal process for promotional materials according to local laws and the Company's policies and standards.
• Collaborating with Medical and business colleagues in initiating and/or responding to regulatory/competitor challenges on promotional practices.
• Initiating, defending, negotiating, settling and managing all litigation and disputes arising from DACH business operations, including adverse reaction claims, promotional disputes and regulatory challenges.
• Liaising with internal and external IP attorneys on IP disputes and IP protection matters.
• Monitoring changes and developments in the legal and regulatory environment in DACH, advising Management, including Offices of General Counsel and Human Health leadership, regarding significant legal and corporate developments and trends in the DACH markets, and providing support in development of appropriate strategies.
• Providing advice and legal support, as needed, on application and maintenance of all authorizations, permits and licenses needed for local operations, including importation, listing/pricing/reimbursement, and marketing of products (such as new product/indication launches), conducting clinical trials, handling adverse experience incidents and implementing product recalls where needed.

Compliance

• Assisting with the interpretation and implementation of Company Standards and Corporate Policies and help ensure compliance of local subsidiary policies and practices.
• Reviewing and advising on commercial and corporate initiatives, innovative collaborations, patient programs, engagements with external stakeholders, etc. across the DACH markets, from a compliance perspective.
• Collaborating with and providing counsel/support to the Business Practices organization and other divisional compliance personnel in the performance of their tasks to enable effective monitoring of compliance and related matters on behalf of the Company in the DACH markets.
• Collaborating with the Business Practices organization to develop, monitor, and implement compliance and risk management strategies and processes, completion of annual certification and country compliance scorecards, and work with divisional compliance officers and management to facilitate sound and prudent business decisions.
• Supporting the development and conduct of legal/compliance training, monitoring, and resolving legal/compliance issues, working with local management and the Business Practices organization to formulate and implement appropriate local business standards and procedures consistent with local laws, US laws (including the US Foreign Corrupt Practices Act (FCPA)), industry codes and corporate policies, among others.
• Preparing and reviewing communications with external parties, including the government, industry associations and the public, including disease awareness campaigns and corporate communications, as well as communications on issues such as healthcare legislations/policies, legal matters and compliance standards.
• Providing support to investigations and internal assessments and related remediations and operations in DACH by the Global Security, Audit and Global Investigations divisions.

Qualifications and Skills

Qualifications, Experience and Language Proficiency

Required:

• Admitted to practice law in a DACH country, Germany preferred
• Minimum 10 years post qualification legal and compliance experience, preferably in the pharmaceutical industry
• In-house experience in a multinational organisation; and/or experience in a top tier law firm

• Language ability: fluency in English and German

Preferred:

• In-house legal and compliance experience with a pharmaceutical company or US-based multinational organisation
• Private practice experience in advising the pharmaceutical industry
• International experience; experience working in multiple jurisdictions
• Knowledge of US and European anti-corruption laws (including US FCPA) and the EFPIA Codes
• Professional or academic legal qualification or experiences in multiple jurisdictions

• Strong understanding of compliance frameworks, risk management, and governance and experience in implementation.
• Additional degrees in science or business disciplines

Skills

• Proven ability to lead and manage legal and compliance teams effectively.
• Ability to identify key issues and consistently apply a high standard of integrity, professionalism, legal knowledge and expertise and business ethics.
• Ability to develop and implement strategic plans to align legal and compliance functions with overall business goals.
• Strong drafting and negotiation skills
• Ability and interest to learn about compliance, to critically review and advise on business programs and procedures in accordance with both legal requirements and corporate policies and standards.
• Highly developed technical and research skills, good attention for details and ability to perform investigations and interviews effectively.
• Ability to think broadly with an enterprise mindset.

• Superlative communication skills, both verbal and written, including skills to articulate legal concepts to non-legal stakeholders.
• Ability to work independently and prioritise work under pressure; being proactive, pragmatic and responsive.
• Strong relationship-building skills to work effectively with various stakeholders, including executives, regulators, and external legal counsel.

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