Experience Inc. Jobs

Manager, Global Labeling Product Leader - 2406193391W

Description

Johnson & Johnson Innovative Medicine is recruiting for a Manager, Global Labeling Product Leader. The position can be based at any of the following R&D sites: US (Titusville, NJ; Raritan, NJ; or Spring House, PA), Canada (Toronto, Ontario), UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse), or Switzerland (Allschwil, Bern, Zug).

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.

In this role, you will:

• Have responsibility for the development and maintenance of primary and derived labeling documents for assigned compounds in assigned portfolio.

• Participate in creation of, and maintain primary labeling documents – the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI) – and derived documents (labeling text for EU, US).

• Coordinate the development, revision, review and approval of primary and derived labeling documents, including the Labeling Working Group (LWG) and Labeling Committee (LC) activities related to these documents.

• Ensure the dissemination of internally approved CCDS, USPI, EUPI and derived labeling documents and supporting documentation; work with other functions to ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).

• Contribute to and participate in the global labeling strategy including the development of target labeling.

• Contribute to the continuous improvement of the end-to-end labeling process.

Qualifications

• A minimum of Bachelor’s degree (or equivalent) is required.

• A degree in scientific discipline is highly preferred.

• An advanced degree (MS, PhD, MD or PharmD) is highly desired.

• Minimum of 4 years of professional experience required.

• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 3 years of direct regulatory labeling content experience or equivalent is highly desired.

• Previous experience working within a regulatory labeling function developing labeling content for pharmaceutical products is highly preferred.

• Experience working in documentum-based systems preferred

• Experience leading project teams is preferred

• An understanding of prescription pharmaceutical drug development is preferred

• Solid understanding of biology and pharmacology is highly desired

• A demonstrated proactive approach, and exceptional verbal and written communication, negotiation and partnering skills are highly desired.

• Participation in continuous improvement projects, and demonstrated ability to drive a collaborative, customer-focused, learning culture is preferred.

• This position can either be based remotely or at any of the following R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA), Canada (Toronto, Ontario), UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse), or Switzerland (Allschwil, Bern, Zug); it may require up to 10% domestic and international travel

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 $113,000 - $195,500.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $139,000 to $224,825.

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.

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

• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on 6/17/24. 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.

Primary Location NA-US-New Jersey-Raritan

Other Locations Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-Netherlands, NA-US-New Jersey-Titusville, NA-United States, NA-Canada, Europe/Middle East/Africa-Switzerland-Berne-Bern, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Basel-Country-Allschwil, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Belgium, NA-CA-Ontario-Toronto, NA-US-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization Janssen Research & Development, LLC (6084)

Job Function Regulatory Science

Req ID: 2406193391W