Legal Manager

Celltrion USA; Jersey City (NJ); On-site; USD 130,000 - 180,000; Full time

Job summary

Celltrion USA, the U.S. subsidiary of Celltrion, is seeking a Legal Manager to support FDA regulatory, marketing, market access, and contract matters.

The role involves advising on legal strategy, reviewing materials for compliance, and enabling commercial success across departments. Reporting to the Director, Legal, you will collaborate across functions, draft and review commercial agreements, and help ensure ethical, compliant communications and pricing strategies for biosimilar products in

Qualifications

• 5+ years as lawyer for a pharmaceutical company.
• Strong knowledge of Life Science Compliance and FDA advertising and promotions law.
• Experience with general commercial contracting and external communications legal concerns.

Responsibilities

• Review promotional, nonpromotional and scientific materials and help develop strategies for US medical affairs and marketing plans.
• Provide legal and regulatory advice to Marketing, Sales, Patient Support, and Medical Affairs teams.
• Review and draft contracts (MSA, SOWs, CDAs) and assess compliance risks in consultation with the Director, Legal.
• Advise on customer relations, regulatory matters, and biosimilar contract matters.
• Collaborate with other legal colleagues to advance company objectives and support training for employees.

Skills

FDA regulations

Legal writing

Compliance knowledge

Contract review

Education

Juris Doctorate

New Jersey bar admission

Job description

Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.

Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.

POSITION SUMMARY

Reporting to the Director, Legal of Celltrion USA, Inc. (“Company”), Legal Manager will work collaboratively across the organization and assist the Director, Legal in FDA regulatory, product marketing, market access, commercial contracts and associated matters. This role will assist in setting legal strategy and policies that enable success of FDA regulatory and product marketing and patient support objectives and enable commercial success of Commercial Department, Medical Affairs and Market Access initiatives.

KEY ROLES AND RESPONSIBILITIES

• Reviews promotional, nonpromotional and scientific materials and will assist with developing strategies, evaluating strategic and tactical commercial/brand and US medical affairs plans, supporting clinical educator programs, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, advertising, marketing, product development, product labeling, promotional review, media materials, anti-kickback, competitor issues, regulatory policy, medical, privacy, sales, industry and company issues.
• Provides well-founded advice on legal and regulatory issues arising from the US Marketing, Sales, Patient Support, and Medical Affairs teams.
• Responsible for contract review relating to vendors products, support for regulatory, marketing, medical affairs and market access and the lawyer will report, evaluate and develop mitigation plans as to potential compliance risks in consultation with Director, Legal in connection with related matters.
• Provide legal strategic advice regarding customer and other stakeholder relationships, regulatory matters, contracts, and interactions with respect to biosimilar pharmaceuticals.
• Partners with other legal colleagues in executing and enhancing Company objectives.
• Assists in supporting compliance function; helping to create and deliver training to employees.
• Ability to forge strong working relationships with employees in different disciplines and at all levels of the organization.
• Demonstrate high standards of conduct and ethics as well as appropriate judgment, independence, and discretion.
• Ability to be proactive, exercise judgment and manage multiple responsibilities simultaneously.
• Review and draft general commercial agreements, as needed (e.g., MSA, SOWs, CDAs).
• Seek legal advice from Director, Counsel or designee in connection with decision-making throughout the process.
• Performs any other matters specifically assigned.

WORK EXPERIENCE

• 5+ years of experience working as lawyer for a pharmaceutical company.
• Strong knowledge of Life Science Compliance, and the law and regulations governing FDA Advertising and Promotions, Medical Affairs, Market Access and Patient Support best practices and materials, contracts and external communications legal concerns.
• Knowledge of general commercial contracting.

SKILLS AND SPECIFICATIONS

• Strong knowledge of compliance, laws and regulations governing marketing and promotions for pharmaceutical products and best practices for non-promotional, Medical Affairs and scientific materials.
• Comfortable working in a fast-paced and evolving environment and demonstrated ability to evolve and align the legal review of marketing/non-promotional materials function with changing business needs.
• Strong verbal and written communication skills, including experience explaining and educating internal stakeholders on FDA Regulations relating to Marketing/Medical Affairs/Patient Support.
• Must be able to work effectively in a multi-cultural, global team environment.

EDUCATION

• Juris Doctorate degree is required.
• Must be admitted to New Jersey bar.
• Alternatively, must be licensed to practice law in at least one (1) state and in good standing and immediately eligible for New Jersey In-House Counsel Limited License.

CORE COMPETENCIES

• Action Oriented
• Conflict Management
• Timely Decision Making
• Priority Setting
• Drive for Results

Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.