Johnson & Johnson is currently seeking a Regulatory Operations Senior Analyst to join our Specialty Compliance team located in Titusville, NJ or Horsham, PA.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/. 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.The Regulatory Operations Senior Analyst will report directly to the Manager, Specialty Compliance Regulatory Operations and will serve as a member of the Regulatory Operations team to deliver on the coordination of tasks, resources, and priorities impacting Regulatory Operations function, including aligning support to business needs (e.g. submissions related to high-volume launches, safety updates, etc.). Key responsibilities will include:
Partner with business to ensure that emerging advertising and promotion technologies and mediums are consistent with applicable laws, regulations, guidelines and company policies related to the submission of advertising and promotion materials (e.g. maintenance of high-quality and compliant submission to FDA of all promotional materials)
Cultivate partnerships to ensure that submissions are timely, accurate, and consistent with FDA requirements, ensure proper record keeping and retention of submission in the system, partner with the Law Department and external counsel to respond to litigation document requests and update and train business on new FDA guidances, advising on process solutions (policies, systems, etc.) to support changing business models.
Serve as an engaged member of the NA Program Management team with responsibilities for providing updates and driving consistency, engaging in strategy development, and providing oversight of projects and initiatives to advance the promotional compliance framework, including partnering to embed FDA requirements into the business and being responsible for engaging in a variety of tasks and initiatives, including many that call for sound judgment and independent initiative
Possess strong Program Management experience collaborating with various business partners.
General understanding to support coordination (& lead where vital) across initiatives to define a standardized methodology and approach to value creation; align organization to definitions/calculations for realization, adoption across initiatives, and analytics/reporting/metrics that reflect Specialty Compliance Organizational initiatives.
Continually evaluate the organization’s ability to deliver value on reporting and insights and create & deliver compliance value recommendations for change where applicable.
Help to drive functional area communications strategy, including change management activities, management of outward facing portals, and establishment of Champion Networks
Serve as an active participant on projects to streamline workflows within functional areas as assigned.
Hold technical writing expertise with the ability to make significant and creative contributions to overall user engagement materials including presentations, guides, portals, slide decks, etc.
Work in collaboration with leadership to create, execute and align the strategy for roll out of new systems and tools
QualificationsEducation:
A minimum of a Bachelor’s degree is required.
Experience and Skills:Required:
A minimum of 2-4 years of relevant professional experience required. Experience in pharmaceutical and/or biopharmaceutical industry is preferred.
Demonstrated ability with complex problem solving; excellent written and verbal communications are required.
Comfort in delivering clear and concise instructions and trainings to groups of audiences from line level to senior leadership staff is required.
Advanced EXCEL, PowerPoint and data management skills are required.
Knowledge of Analytical Tools (e.g. Qlik, Tableau, SPSS or SAS) required.
Preferred:
Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines, and enforcement trends is preferred.
Experience supporting FDA 2253 submissions and product launches is preferred.
A demonstrated track record of successful business experience in other related functional areas, such as Data Sciences, Regulatory, Health Care Compliance, Medical/Scientific Affairs, Sales, Marketing, Legal, etc. is a plus.
Strong Program Management experience collaborating with cross-functional business partners.
Other:
Must be able to travel up to 10%, mainly to domestic destinations.
The anticipated base pay range for this position is $77,000-$124,200. 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:
o Vacation – up to 120 hours per calendar yearo Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearo Holiday pay, including Floating Holidays – up to 13 days per calendar yearo Work, Personal and Family Time - up to 40 hours per calendar yearFor additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThis job posting is anticipated to close on November 26, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.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.