Johnson and Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior RA Professional, Global TA (1 of 2). Desired assignment location is New Jersey or Pennsylvania and may require local travel. Flexible work arrangements may also be considered.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Caring for the world one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science, bringing innovative ideas, products, and services to advance the health and well-being of people. And, at Johnson & Johnson Innovative Medicine, we use heart, science, and ingenuity to create transformational medicines to improve the health of humanity. Every day, we work to advance scientific research and commercial innovation, to deliver solutions that provide value to patients, physicians and healthcare systems around the world. Growing on a diverse company culture, we celebrate the uniqueness of our employees and are committed to inclusion.
Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter who is passionate about advancing their career in healthcare.
What's it like to be a Senior RA Professional, Global TA?
GRA is a key strategic partner supporting global R&D initiatives at Johnson & Johnson Innovative Medicine. As a Senior RA Professional, Global TA you will support drug development programs as well as marketed products across multiple therapeutic areas. You will gain broad and diverse regulatory experience supporting compounds in early to late drug development as well as life-cycle activities for approved products in our portfolio via a flexible rotational model geared towards addressing business needs and individual career-development goals.
Through hands-on, real-world experiences, you will work on projects that improve your leadership, problem solving, and creative thinking skills. Furthermore, you will acquire the business savvy to be successful in a complex, fast-paced, and innovative regulatory environment.
Responsibilities:
- Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned.
- Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.
- Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed
- Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy
- Work cross-functionally, interact with internal and external colleagues with coordination between departments, and lead team meetings as appropriate
- Advise team in required documents and submission strategies
- Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements
- Support the development and improvement of processes related to regulatory submissions
- Provide regulatory input for and follow-up to inspections, audits, litigation support, and product complaints
- Stay on top of current and pending approvals in assigned therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas.
- May interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact to represent J&J/Janssen externally with some degree of supervision
Qualifications
Education:
- Minimum of a Bachelor's degree in a scientific or equivalent discipline
Required:
- Minimum of 6 years relevant industry experience, depending on educational level achieved
- Previous experience in a health regulated industry
- Understanding of the drug development process
Preferred Experience:
- Understanding of regulatory submission and approval process and applicable US and EMA regulatory guidelines
- Relevant regulatory affairs experience in pharmaceutical/biotech
- Experience responding to HA requests, managing HA interactions, and life cycle management applications
- Diverse therapeutic area experience
- Experience within a cross-functional team environment as an individual contributor and decision maker
Leadership Capabilities
- Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues
- Influences or persuades others within area of immediate responsibility, scope, and level to accept new ideas, practices and approaches
- Skilled at project managing and effectively prioritizing assignments for multiple projects simultaneously
- Strong interpersonal and communication skills
Desired assignment location is New Jersey or Pennsylvania and may require local travel. Flexible work arrangements may also be considered.
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.
The anticipated base pay range for this position is 105000 to 169050.
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 and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
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.