As part of the Otsuka US Legal Team, the Senior Director, Corporate Counsel will bring an expert understanding of the pharmaceutical industry and the legal implications of initiatives and strategies. With many 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. In order to be effective counsel, they maintain familiarity with laws that affect areas of Otsuka's operations, including those relevant to sales and marketing of products to health care professionals and reimbursement by government programs, including, for example, fraud and abuse (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act).
As a Senior Director within the Legal team, it is expected the incumbent will have exceptional business counseling gravitas and, having built strong, trusting relationships with business partners, is able to influence and guide multi-functional teams to achieve optimal business outcomes. The Senior Director, Corporate Counsel also has primary responsibility for internal advice-giving and interpretation of relevant laws, rules, regulations, and guidelines in support of both Otsuka's mission of better health worldwide and Otsuka's purpose to defy limitation so that others can too.
At Otsuka our mission is to create new products for better health worldwide. Our purpose is to defy limitation so that others can too.
Otsuka is committed to diversity and inclusion in the workplace. Individuals seeking employment at Otsuka are considered without regards to race, color, religion, sex, sexual orientation, gender identification, national origin, age, marital status, ancestry, physical or mental disability, veteran status, or genetic information, among other protected bases.
To that end, the Legal Affairs department at Otsuka is seeking qualification as a Mansfield Rule 3.0 Certified Law Department as part of the Diversity Lab's Mansfield Rule initiative, which measures and seeks to increase diversity within law departments. Providing your data during the application process helps us with achieving that goal and with meeting reporting/record-keeping obligations under federal and state law and other legal requirements. Providing your data is entirely voluntary and will not be considered in the hiring process or thereafter. Any information that you do provide will be treated confidentially.
Specific Role Responsibilities:
Senior Director Responsibilities
- Provide Legal support for commercialized brands through review of promotional and disease state materials and all related sales and marketing activities to ensure regulatory and legal compliance
- Maintain a deep and current awareness of evolving FDA and OPDP regulations and interpretations, advisory comments, enforcement actions and policy issues;
- Oversee Legal Affairs promotional review practices, including training Legal Affairs staff on laws, regulations, company policies and best practices to ensure consistent standards and risk acceptance across all review committees supported by Legal.
- Effectively partner with Medical Affairs, Regulatory Affairs, Marketing and other Commercial colleagues to ensure promotional labeling, advertisements and educational materials are reviewed in a timely fashion throughout the product life-cycle;
- Collaborate with internal clients at all levels, including but not limited to, Marketing, Managed Markets, Sales, Medical Affairs, and Global colleagues in legal and compliance matters
- Work closely with other Corporate Counsel to administer policies, procedures, and guidelines in core compliance areas (such as antikickback, antitrust, antibribery, data privacy & security)
- Perform other legal, administrative and corporate duties upon request
- Legal: Manage the provision of a significant legal service specialty.
- Solutions Analysis: Identify and evaluate complex, expertise-led solutions against a range of criteria to find the ones that best meet business needs.
- Internal Client Relationship Management: Manage relationships with internal clients and act as a business partner to them, building high levels of professional credibility and mutual trust, and managing the deployment of appropriate internal and/or external resources to support in delivering business strategy and plans.
- Performance Management: Develop and propose own performance objectives. Manage and report on team performance; set appropriate performance objectives for direct reports or project / account team members and hold them accountable for achieving these, taking appropriate corrective action where necessary to ensure the achievement of team / personal objectives.
- Recommendations: Recommend changes to policies, processes, standards and practices that would improve operational support.
- Information and Business Advice: Provide specialist advice on the interpretation and application of policies and procedures, resolving queries and issues and referring very complex or contentious issues to others.
- Research: Develop and/or deliver a plan for significant aspects of a research program with guidance from senior colleagues.
- Risk Scenario Modeling: Undertake strategic and tactical risk modeling and scenario planning to support business strategy and to identify and mitigate risk in line with the risk appetite. Advise on operationalizing risk appetite.
Decision Quality: Makes good and timely decisions that keep the organization moving forward.
Ensures Accountability: Holds self and others accountable to meet commitments.
Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
Persuades: Uses compelling arguments to gain the support and commitment of others. F
Develops Talent: Develops people to meet both their career goals and the organization's goals.
Strategic Mindset: Sees ahead to future possibilities and translates them into breakthrough strategies.
Plans and Aligns: Plans and prioritizes work to meet commitments aligned with organizational goals.
Customer Focus: Builds strong customer relationships and delivers customer-centric solutions.
Business Insight: Applies knowledge of business and the marketplace to advance the organization's goals. Monitors business news and market changes for impact on the business or on own expertise area; uses this to shape decisions.
Manages Ambiguity: Operates effectively, even when things are not certain or the way forward is not clear.
Policy and procedures: Works without supervision and provides technical guidance when required on developing, monitoring, interpreting and understanding policies and procedures, while making sure they match organizational strategies and objectives.
Questions Strategically: Works without supervision and provides technical guidance when required to uncover clients' explicit needs and/or unforeseen opportunities and challenges..
Negotiation: Uses comprehensive knowledge and skills to negotiate independently while providing guidance and training to others
Analyze Alternatives and Recommend Solutions: Works with full competence to analyze potential solutions and create recommendations based on the expected benefits, costs, and overall value of the solution for key stakeholders.
Policy and Regulation: Works without supervision and provides technical guidance when required on interpreting and applying knowledge of laws, regulations and policies in area of expertise.
Legal Communication: Uses comprehensive knowledge and skills to act independently while guiding and training others on how to communicate effectively on legal matters.
Legal Research: Uses comprehensive knowledge and skills to act independently while guiding and training others on researching and applying legal concepts and information.
Effectively Presents Solutions: Uses comprehensive knowledge and skills to act independently while guiding and training others to clearly present solutions that link directly to the key objectives and challenges important to the client.
Project Risk and Issue Management: Works without supervision and provides technical guidance when required on identifying, assessing, prioritizing and managing project-related risks.
Project Governing: Works with full competence to identify, select, and manage the oversight of projects, programs, and portfolios
- Minimum of 10 years of combined relevant experience as an attorney at a law firm and in the pharmaceutical industry
- Experience & demonstrated ability to collaborate, build and sustain effective partnerships with multicultural key stakeholders and project teams
- This role can be located in Otsuka's Princeton, NJ or Rockville, MD offices, or it can be remote, but availability during US Eastern time zone business hours is mandatory. No matter where the role is located, up to 25% travel is required based upon business needs.
- Doctor of Jurisprudence (J.D.) or equivalent degree and admission to at least one state bar is required
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.Statement Regarding Job Recruiting Fraud Scams
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