Executive Director, Deputy GC

As the Deputy General Counsel at Otsuka Precision Health, you will play a critical role in ensuring legal compliance and mitigating risk across all aspects of our operations, with a particular focus on supporting patient programs and products (e.g. – Patient Support Programs, Digital Health solutions, diagnostic algorithms, use of AI and clinical decision support solutions) for our clients in the pharmaceutical and MedTech industries. We are looking for an experienced attorney (15+ years) with expert understanding of the legal and regulatory issues and implications involved with developing and commercializing aforementioned solutions, and you will be responsible for advising senior management on legal matters, developing and implementing policies, procedures, and overseeing contract negotiations. Expertise in healthcare laws and regulations, including Anti-kickback Statute (AKS), Stark Law, HIPAA, and FDA Regulations will be essential in guiding our company’s activities and maintaining our reputation for integrity and excellence.

The person in this role has significant responsibility for overseeing and implementing best practices for all the company review processes and policies that cover the various business activities that require legal, compliance, and regulatory review. This includes collaborating and managing shared service support to achieve consistent and efficient processes to support product support and development, patient support services, and all other goals and initiatives of the evolving Otsuka Precision Health organization. This person will manage one or more senior attorneys and has supervised legal work for several functional areas. The Deputy General Counsel collaborates with the General Counsel on complex and first-impression matters, provides hands-on and specific sponsorship of others in and outside the department, and is recognized as an influential leader. The Deputy General Counsel exemplifies collaborative culture and drives joint accountabilities across multiple stakeholders. The Deputy General Counsel establishes strategy and direction for the legal support of the functional areas of responsibility in alignment with strategic plans established by executive leadership.

Job Description

With 15+ years of applicable experience, the incumbent will be a big-picture thinker who is able to anticipate changes in law, environment and company objectives and manage and mitigate risk accordingly. To be effective and strategic, they maintain familiarity with laws that affect areas of Otsuka Precision Health’s operations, including those relevant to digital health solutions, devices and diagnostics, product development, interactions with health care professionals, patient support programs, and regulatory constructs related to reimbursement and telehealth. The individual will have ample experience providing counsel and advice to business clients on matters related to product liability, fraud and abuse (Anti-Kickback Statute, False Claims Act), FDA Regulation (Federal, Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act). As an Executive Director it is expected the incumbent will have exceptional business counseling gravitas and can build strong, trusting relationships with business partners, executive leadership, the Board of Directors and is able to influence and guide multi-functional teams to achieve optimal business outcomes.

Responsibilities:

Provides advice, guidance, and counsel to cross-functional teams on product strategies, programs, policies, practices, and initiatives in compliance with all relevant and applicable laws, guidance documents or opinions, and industry codes.

Oversees the review processes, including implementing best practices, for a variety of business activities that require review, including but not limited to, review committee (RC)

Interacts with various internal clients and functional groups to effectively address legal and business questions and provide guidance as well as practical solutions as needed.

Defines legal and regulatory risks and clearly communicates and explains those risks to appropriate internal decision-makers for discussion and resolution.

Maintains current knowledge of laws and regulations related to Patient Support Programs and MedTech development and commercialization and provides counsel and training on recent changes and enforcement actions as well as potential implications for our business operations.

Supports administrative law activities as needed, such as reviews of government agency actions or requests for agency interpretation of regulatory enforcement issues.

Provides effective legal support for matters regarding the development and commercialization of products and product candidates and ensures that current decisions align with long-term organizational goals.

Fosters a culture of ethics and transparency and collaborates with all departments to improve compliance and governance infrastructure.

Supports development of effective compliance policies, standards, and procedures.

Collaborates with, counsels, and coaches colleagues in other functional areas as well as other attorneys and support staff working on complex issues and transactions

Responsibly manages the efficiency and effectiveness of outside law firms when engaged in strategic matters, with ultimate accountability for the preparation of law firm budgets and the overall quality and timeliness of such firms’ output.

Qualifications/ Required

Knowledge and Skills Required:

JD and bar admittance in appropriate state

More than 15 years of relevant experience, with more than 5 years of managerial experience.

Knowledge of general corporate transactions and matters (e.g., contract, business, litigation, and regulatory law)

Ability to analyze, interpret, and apply government regulations, guidelines, and requirements.

Ability to identify problems and work to implement solutions.

Ability to exercise good judgment regarding the interpretation of policies, development of procedures, and selection of appropriate courses of action.

Excellent judgement, time management, communication, and cross-functional collaboration skills

Ability to work in a team and assist others as needed.

Strong preference for individuals with in-house, firm, and regulatory agency experience.

Educational Qualifications

Juris Doctorate (J.D.)

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $277,341.00 - Maximum $430,560.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

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