Associate Director, Global Labeling Product Leader

Job title: Associate Director, Global Labeling Product Leader in Raritan, NJ at reputed company Company: reputed company Job reputed company: At Johnson & Johnson, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at https://www.jnj.comJob Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category: reputed companyreputed company Job Posting Locations: Horsham, reputed company, reputed company of America, Raritan, New Jersey, reputed company of America, Titusville, New Jersey, reputed company of AmericaJob reputed company:About Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of reputed company.Join us in developing treatments, finding cures, and pioneering the reputed company from lab to life while championing patients every reputed company of the way.Learn more at https://www.jnj.com/innovative-medicinePlease note that this role is available across multiple countries and may be posted under different requisition numbers to reputed company with local requirements. While you are welcome to apply to any or reputed company of the postings, we recommend focusing on the specific country(s) that reputed company with your preferred location(s):reputed company - Requisition Number: R-008331Canada - Requisition Number: R-009630Belgium - Requisition Number: R-009644United Kingdom - Requisition Number R-009647Switzerland - Requisition Number: R-009649Remember, whether you apply to one or reputed company of these requisition numbers, your applications will be considered as a single submission.Johnson & Johnson Innovative Medicine R&D is reputed company for an Associate Remote work reputed company may be considered on a case-by-case reputed company and if approved by reputed company. While specific cities are listed in the Locations reputed company for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.Director, Global Labeling Product Leader. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; Horsham, PA.The Associate Director, Global Labeling Product Leader will be responsible for the following:reputed company the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), reputed company Package Insert (USPI) and associated patient labeling, European reputed company Product Information (EUPI), and derived documents (labeling text for EU, US)) for assigned compounds.reputed company recommendations and provides advice and guidance about labeling content, processes, timelines, and scientific reputed company. Coordinate the reputed company of any labeling issues with potential reputed company on the primary or derived labeling, or the supporting documentation. Ensure high reputed company and compliant labeling documents. This role may collaborate with external partners.Contribute to and implement the global labeling reputed company, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and reputed company labeling.Contribute to the reputed company improvement of the end-to-end labeling process.Qualifications:A minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.A minimum of 8 years of reputed company work experience is required.A minimum of 6 years of reputed company regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.An understanding of pharmaceutical drug development is required.Experience in discussing and communicating scientific concepts is required.Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required.Experience leading project teams in a reputed company environment is required.Experience leading reputed company improvement reputed company is required.Experience working with document management systems is required.Experience effectively/appropriately prioritizing and managing multiple products and reputed company simultaneously is preferred.Must have exceptional verbal and written communication skills.Must have strong organizational, negotiation, and partnering skills.Must have the ability to work independently.The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.The ability to drive a reputed company, customer-reputed company, learning culture is preferred.The anticipated reputed company pay reputed company for this position in the San Francisco Bay Area, CA is $168,000 to $271,400.The anticipated reputed company pay reputed company for this position in reputed company other U.S. locations is $137,000 to $235,750.reputed company maintains highly competitive, performance-based compensation programs. Under reputed company 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 reputed company an incentive to reputed company annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at reputed company’s discretion on an individual reputed company.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in reputed 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 yearreputed company time - up to 40 hours per calendar year; for employees who reputed company in the reputed company - 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 yearFor additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThe compensation and benefits information set forth in this posting applies to candidates reputed company in the reputed company.Candidates reputed company reputed company the reputed company will be eligible for compensation and benefits in accordance with their local market.This job posting is anticipated to reputed company on reputed company 28, 2025. reputed company may however reputed company 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 Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company.reputed company is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee reputed company (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.#LI-HybridThe anticipated reputed company pay reputed company for this position is : The anticipated reputed company pay reputed company for this position in the San Francisco Bay Area, CA is $168,000 to $271,400. The anticipated reputed company pay reputed company for this position in reputed company other U.S. locations is $137,000 to $235,750.Additional reputed company for Pay Transparency: For US: Calculate the salary to be included based on the compensation reputed company provided in the requisition. Duplicate the WR window to reputed company the details. As applicable for your role: reputed company 1: Review Pay Transparency Compliance Work Instructions for reputed company - reputed company reputed company 2: Manually include the minimum salary to 115% of the midpoint. Please follow the guidelines for exceptions (LDP, Coops, 100% commissions, Fixed salary, Sales and releveling) reputed company 3: Please copy the relevant benefits text based on the type of position and paste in the field: Additional reputed company for Pay Transparency. reputed company 4: If your primary, alternate, or remote location is in the California Bay Area, please manually add the applicable second reputed company in the “Applicable Pay reputed company” field. DELETE ANY BENEFITS reputed company TO THE POSITION OR INCLUDE ANY ADDITIONAL BENEFITS APPLICABLE: reputed company maintains highly competitive, performance-based compensation programs. Under reputed company 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 reputed company an incentive to reputed company annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at reputed company’s discretion on an individual reputed company. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in reputed company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year reputed company time - up to 40 hours per calendar year; for employees who reputed company in the reputed company – 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 reputed company through the reputed company below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates reputed company in the reputed company. Candidates reputed company reputed company the reputed company will be eligible for compensation and benefits in accordance with their local market. Expected salary: Location: Raritan, NJ Apply for the job now! Apply for this job