Senior Manager, Corporate Counsel

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Job Summary:

The Senior Manager, Legal Business Partner, will be a member of and support the Legal Department at Kyowa Kirin, Inc. in delivering consistent, high-quality legal support across commercial brands, contracting, privacy, and select global initiatives.  Working under the supervision of senior attorneys, this attorney will provide legal support to internal clients and cross-functional partners, ensuring that company strategies, programs, and materials comply with applicable laws, regulations, and company policies. This is a great opportunity for an attorney to deepen their expertise in brand strategy, commercial strategy execution, privacy, and healthcare compliance and regulatory frameworks, including the Anti-Kickback Statute, False Claims Act, Food, Drug, and Cosmetic Act, relevant OIG guidance documents, and state and federal privacy laws.

Essential Functions:

• Support senior attorneys in providing legal guidance to commercial, medical affairs, market access, and compliance teams for marketed and late-stage products.
• Assist in the review of product promotional and medical materials as well as business-related materials (e.g., commercial brand plans, strategic initiatives, training documents, market research proposals) to ensure compliance with applicable laws, regulations, and company policies.
• Support senior attorneys on matters related to healthcare laws, regulations, and industry best practices, including the Anti-Kickback Statute, the False Claims Act, the Food, Drug, and Cosmetic Act, the Sunshine Act, OIG guidance documents (e.g., Advisory Opinions, Special Fraud Alerts), and the PhRMA Code. Matters include, among other things, advertising and promotion strategies and activities, dissemination of scientific information, market access initiatives, patient engagement and advocacy, patient services / support programs (e.g., HUBs, co-pay programs, bridge programs), and other matters relevant to the development and commercialization of prescription products.
• Prepare legal guidance documents, training materials, and resources for internal clients and cross-functional partners.
• Draft, review, negotiate, and finalize a wide variety of agreements, including, without limitation, master service agreements, statements of work, confidential non-disclosure agreements, as well as consulting, advisory board, speaker program, ambassador, and external funding (e.g., sponsorships, educational grants) agreements.
• Drive the contracting process from initiation through execution via the company’s contract management system while liaising with senior attorneys and internal business partners as needed.
• Support Privacy Counsel with privacy and data protection initiatives, including maintaining records of processing activities (ROPAs), conducting or assisting with data protection impact assessments (DPIAs), and ensuring compliance with applicable data privacy regulations.
• Coordinate with global colleagues on cross-border and intercompany initiatives to ensure alignment with company policies.
• Work with Compliance colleagues to educate internal business partners, vendors, and consultants on applicable company policies, procedures, practices, and expectations.
• Assist with a wide range of general and special legal- and business-related projects and matters as requested by senior attorneys.
• Develop highly effective working relationships throughout the company and operate in alignment with the company’s global values: Commitment to Life; Innovation; Integrity; and Teamwork / WA.

Job Requirements:

Education

A bachelor’s degree from a four (4) year college or university of recognized standing is required. A law degree (JD) from a law school of recognized standing is required. Admission to and good standing with the NJ Bar and/or qualification for NJ limited in-house license (with reciprocal Bar Admission in another state) is required.

Experience

Three to six years of post-JD legal experience (required), including one to two years supporting pharmaceutical, biotech, or medical device clients (preferred).Fundamental knowledge of applicable laws, regulations, and regulator guidance docume