Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
Work in an exciting and challenging legal environment by independently providing innovative and strategic legal support and solutions as a brand attorney and the primary legal advisor for the commercial business and operations supporting U.S. approved (or to be approved) oncology products and to specific assigned business functions in the Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs, Sales, Marketing, Market Access, etc.) including, but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their professional growth and development as well as their achievement of Company and/or departmental expectations and goals as identified by senior management.
Responsibilities
- Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting U.S. approved (or to be approved) oncology products.
Acts as legal advisor for assigned corporate business and functional areas of the Daiichi Sankyo Oncology Business Unit and US Oncology Business Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs) as well as DSI employees performing Global roles in the United States (such as Global Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and support for the business aspects of those functions. Prepares legal documents such as contracts, correspondence (e.g., to regulatory agencies), both independently and for review, approval, and use by Legal Affairs management. Independently negotiates contracts and other issues with third parties (vendors, etc.). Manages, as assigned, outside lawyers and contracted legal counsel assigned to specific corporate business or functional areas of the Daiichi Sankyo Oncology Business Unit and US Oncology Business Division of the Company. Specific assignments to be determined by direct manager of the role.
- Creates, implements, and presents training programs and materials on legal issues for various departments. Monitors current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding same.
- Leads cross-functional project management teams set up to address mid-sized to large Company-driven initiatives or special projects-internal to the Company as well as project involving external business partners and/or other entities. The result of such initiatives may include creating corporate-level policies, guidance documents (i.e. standing legal risk analyses), and training of Company employees.
- Monitors current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding same (including Legal Affairs Department colleagues). Works independently and, as appropriate, in collaboration with other departments in developing, implementing and presenting training materials on various legal issues pertaining to assigned business areas. Such training materials may be presented to functions supported by this position (or by them) but would also be available for use by the Legal Affairs Department generally.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree required
- JD from Law School of recognized standing, and Bar Admission in NJ (direct admission or eligible for limited in-house licensing in NJ.) required
Experience Qualifications
- 7 or More Years of post-law school experience required
- 4 or More Years experience in regulatory, compliance, and legal matters relating to investigational products, product promotion, scientific exchange, and disease state communications (including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, state and federal data privacy laws, and product liability laws) required
- 7 or More Years pharmaceutical industry experience, particularly supporting specific assigned products and business areas in contracting, general legal advice, policy development and/or review, etc. in specific business support functions in an in-house capacity, as a legal consultant, and/or at a law firm in a practice group focusing on pharmaceutical industry and/or specific corporate business functions preferred
- Experience with Veeva Vault PromoMats preferred
- Experience with pricing and Market Access preferred
- Experience with Government Affairs preferred Licenses and Certifications
- Eligible to practice law in the state of New Jersey (either licensed in NJ or limited in-house license) and maintain such license in good standing at all times. required
Travel
Ability to travel up to 5%. Occasional travel required
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
