Description
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $93.8 billion in 2021 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Global Legal Organization is recruiting for a MedTech Regulatory Law Paralegal, to be located in New Brunswick, NJ, West Chester, PA or Raynham, MA.
Description/Responsibilities :
The MedTech Regulatory Law Paralegal will:
· Review advertising and promotional materials for a range of medical devices to ensure compliance with applicable laws and regulations, working closely with a supervising regulatory attorney. This activity will include collaborating with Regulatory Affairs, Marketing, Medical Affairs, Medical Safety, Healthcare Compliance, Research & Development and Communications subject matter experts and partners.
· Coordinate with promotional review teams and marketing to deploy and maintain a database of approved claims with underlying substantiation. Additionally, the paralegal will be responsible for helping the commercial organization develop product claims and program communications in an efficient and compliant manner.
· Be responsible for engaging in a variety of tasks ranging from consistent application of established standards to those calling for judgment and independent initiative.
The successful candidate will have knowledge of industry practices and standards applicable to regulated companies in the medical device and/or pharmaceutical industry. They must be detail oriented, collaborative, and capable of working on both teams and independently. They must also be comfortable with the use of technology tools and asset management platforms.
o Approximately 6-8 hours per week would be spent in meetings reviewing materials and discussing proposed marketing claims with the business platform copy review teams.
o Approximately 8-10 hours per week would be spent reviewing materials independently, usually utilizing asset management platforms.
o Approximately 1-2 hours per week would be spent on MedTech Regulatory Law, Global Regulatory Law or Global Legal Organization projects and initiatives.
Qualifications
· An Associate’s degree or paralegal certificate is required. A Bachelor’s degree is preferred.
· A minimum of 4 years of experience as a paralegal or in-house related experience is preferred.
· Prior experience in the pharmaceutical or medical device industry is desired.
· Proficiency in the use of technology, document management tools (e.g. MS Office) and asset management platforms is required.
· This position requires strong written and verbal communication skills and the ability to effectively work with other departments within the Company such as Marketing, Regulatory Affairs, Medical Affairs and Health Care Compliance.
· Must have strong organizational and time management skills and be detail oriented.
· Must be able to travel locally in NJ/PA, approximately 10% of the time.
Time commitment : Approximately 19.5 hours per week.
In accordance with applicable disclosure requirements, the full-time anticipated base pay range for this position is $60,000- $96,600. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .