Counsel, Brand Legal

Counsel, Brand Legal. Reports to Head of Legal, Healthcare Law

Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner.

Job Overview

Sumitomo Pharma America, Inc. (SMPA) is looking for an experienced healthcare attorney who can be successful within our fast-paced, patient-focused culture. This position will support the commercial, medical affairs, compliance, and managed markets functions. This individual will serve as one of the lead attorneys and internal client contact for providing strategic advice on commercial, regulatory, and healthcare compliance issues affecting the marketing and sale of the company’s women’s health and urology products.

Job Duties And Responsibilities

1. Support global product development and commercial operations. Responsibilities include counseling on laws applicable to pharmaceutical promotion and sales, industry codes and promotional practices, risk management, and mitigation related to commercial and clinical matters.
2. Serve as lead counsel for women’s health and urology products, including participation in cross-functional committees charged with setting/implementing commercial and medical strategies as well as reviewing advertising, scientific, and other materials (e.g. promotional review committee, medical review committee, etc.).
3. Work directly with the market access team by providing critical legal advice and guidance related to drug pricing, access, and reimbursement issues.
4. Understand the strategic and tactical objectives of the business and develop thoughtful and practical solutions considering the current legal and regulatory landscape, SMPA’s policies and procedures, and the current and future needs of the organization.
5. Exhibit superior legal skills together with a proficiency for critical thinking and problem solving in a multi-functional environment.
6. Be an informed and accessible resource regarding new laws, regulations, and industry trends affecting the company and the biopharmaceutical sector.
7. Liaise with and support SMPA’s compliance function to ensure risk-based advice is consistent with company policies and training messages that can be implemented in accordance with company procedures.
8. Contribute to highly collaborative culture with effective relationships with peers in the legal department as well as close partnerships with business leaders.

Key Core Competencies

1. Ability to work in a team environment.
2. Works with integrity and ethically in accordance with the SMPA’s Code of Business Conduct and related policies and procedures.
3. Exhibits honesty, integrity, and trust-building behaviors in all interactions.
4. Attention to detail is critical.
5. Self-directed with capacity to collaborate with a team in order to ensure that project milestones are successfully completed.
6. Strong written and oral communication skills, including ability to articulate and communicate with executive leadership.
7. Ability to prioritize responsibilities, to work efficiently, to manage, and to conclude, in a timely manner, projects, and issues.
8. Excellent interpersonal skills and ability to manage internal client expectations and build and maintain productive external relationships.
9. Exercises discretion and good judgment while handling confidential and sensitive information.

Education And Experience

1. Juris Doctor degree from an accredited law school, state bar admission (specific state admission not required).
2. Understanding of the pharmaceutical/life sciences industry.
3. 5 plus years of experience in a healthcare law role in the life sciences industry is preferred.
4. Prior in-house experience as a member of a legal department in a biotechnology or pharmaceutical company is preferred.
5. Experience with new product launches is preferred.
6. Experience at a nationally recognized law firm in an applicable practice area is strongly preferred.
7. Command of relevant laws, regulations, guidance, and industry codes including the federal Food Drug and Cosmetic Act (FDCA) and related FDA Guidance documents, the federal Anti-Kickback Statute, the federal False Claims Act, and the PhRMA Code is required.
8. Working knowledge of the Health Information Portability and Accountability Act (HIPAA) and applicable privacy laws is preferred.

Disclaimer : The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.