Johnson Johnson Innovative Medicine is recruiting for a Manager, Global Labeling Product Leader in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug (Switzerland).
Remote work options may be considered on a case-by-case basis and if approved by the Company.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.Key Responsibilities:Lead the development, revision, review, agreement, and maintenance of primary labeling (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) for assigned compounds.Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity.Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation.Ensure high quality and compliant labeling documents.Contribute to and participate in the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status.Contribute to the continuous improvement of the end-to-end labeling process.Qualifications:Education:A minimum of Bachelor's degree (or equivalent) (required).A degree in scientific discipline (required).An advanced degree (MS, PhD, MD or PharmD) (preferred).Required Skills:Minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance).An understanding of pharmaceutical drug development.Experience in discussing and communicating scientific concepts.Basic understanding of worldwide regulatory guidelines and their applications for guidance for labeling.Experience leading project teams within a matrix environment, combined with the ability to work largely independently with limited supervision.A demonstrated proactive approach, experience participating in continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills.Experience working in document management systems.Preferred Skills:3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent.A successful track record of effectively/appropriately prioritizing and managing multiple products and projects simultaneously.Demonstrated ability to drive a collaborative, customer-focused, learning culture.The anticipated base pay range for this position is to be determined.
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.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 yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearAdditional information can be found through the link below: https://www.careers.jnj.com/employee-benefitsThe 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.
#J-18808-Ljbffr