JobSummary

The Otsuka US Legal Team is looking for an attorney familiar with the legal and regulatory frameworks within which life sciences companies operate. The attorney will provide proactive guidance and counseling related to global and US regulatory affairs, promotion and commercializing branded products. This role offers the opportunity to provide legal advice in many different areas of corporate law, including privacy, business transactions and development of corporate policies, as well as direct legal support to several functional areas of our life sciences business, including sales and marketing, global medical affairs, regulatory affairs and quality.

The Director, Corporate Counsel will have experience in the pharmaceutical industry or at a law firm and be able to bring a foundational understanding of the industry and the other functional areas within a pharmaceutical company. The candidate must demonstrate the ability to understand and apply legal risks within his/her areas of responsibility, and clearly and appropriately communicate those risks for client consideration. As a Director within the Legal team, it is expected the individual will also work independently, be able to develop well- reasoned positions, and know when to appropriately escalate complex and unique topics for further discussion and consideration.

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.

At Otsuka our mission is to create new products for better health worldwide. Our purpose is to defy limitation so 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.

Job Description

Specific Role Responsibilities:

• Maintain a deep and current awareness of evolving FDA laws and regulations, as well as interpretations, advisory comments, enforcement actions and policy issues;
• Partner with internal clients in Regulatory Affairs, Quality, Pharmacovigilance, Clinical Management and Medical Affairs to respond to issues requiring legal support;
• Effectively partner with Medical Affairs, Regulatory Affairs, Marketing and other Commercial colleagues to ensure promotional labeling, advertisements and educational materials are reviewed in compliance with applicable laws and regulations in a timely fashion throughout the product life-cycle;
• Collaborate with, counsel and coach colleagues in other functional areas as well as other attorneys and support staff working on complex transactions;
• Provide guidance to multi-functional teams to ensure compliance with company policies and legal/regulatory requirements;
• Work closely with other Corporate Counsel to administer policies, procedures, and guidelines in core compliance areas (e.g., anti-kickback, antitrust, anti-bribery, data privacy & security); and
• Perform other legal, administrative and corporate duties upon request.

Additional Director Responsibilities

• Solutions Analysis: Analyze specific problems and issues to find the best solutions. Solutions could be technical or professional in nature.
• Policies and Procedures Development: Contribute to the drafting of policies, procedures, and related guidelines within an area of expertise to meet defined key principles and ensure compliance with external requirements.
• Internal Client Relationship Management: Contribute to the management of partnering relationships with internal clients, building effective working relationships, and providing high-quality professional services to support in delivering business strategy and plans.
• Information and Business Advice: Resolve queries from internal or external customers or suppliers by providing information on complex processes and the related policies, referring to others where necessary for interpretation of policy.
• Risk Scenario Modeling: Analyze, assess, and quantify the risks associated with products/individual applications/business activities/the market to determine whether any risk is within the agreed risk appetite. Undertake tactical risk modeling.

Qualifications

EDUCATION:

• Doctor of Jurisprudence (J.D.) or equivalent degree required
• Admission to at least one state bar

EXPERIENCE:

• Minimum of 5 years of relevant experience as an attorney in the pharmaceutical industry or at a law firm advising pharmaceutical clients.
• Experience & demonstrated ability to collaborate, build and sustain effective partnerships with multicultural key stakeholders and project teams

BEHAVIORAL COMPETENCIES:

• 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. For example, states position with conviction and persuasive rationale.
• Develops Talent: Develops people to meet both their career goals and the organization's goals.
• Optimizes Work Processes: Knows the most effective and efficient processes to get things done, with a focus on continuous improvement.
• 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.

TECHNICAL COMPETENCIES:

• Questions Strategically: Works with limited guidance to uncover clients' explicit needs and/or unforeseen opportunities and challenges.
• Analyze Alternatives and Recommend Solutions: Works at an intermediate level 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 with limited guidance to interpret and apply knowledge of laws, regulations and policies in area of expertise.
• Effectively Presents Solutions: Works with limited guidance to clearly present solutions that link directly to the key objectives and challenges important to the client.
• Project Risk and Issue Management: Uses comprehensive knowledge and/or skills to act independently with guiding and training others on identifying, assessing, prioritizing and managing project related risks.