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 documents, including 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 is preferred. General experience reviewing or supporting commercial contracts and familiarity with working in contract management systems is preferred. Familiarity with privacy and data protection concepts, including ROPAs and DPIAs, is preferred.. Strong collaborator, team-player, high integrity, exemplary work ethic, respectful and conscientious. Sound understanding of social media and digital platforms.

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company.

The anticipated salary for this position will be $148,800 to $192,300.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Discretionary Profit Share
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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