Associate Director, Global Labeling Product Leader

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Horsham Pennsylvania United States of America Raritan New Jersey United States of America Titusville New Jersey United States of America

Job Description:

About Innovative Medicine

Our 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 tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at & Johnson Innovative Medicine R&D is recruiting for an Associate 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:

• Drive the global labeling strategy including demonstrating an understanding of competitors in the therapeutic area their development plans and status and knowledge of labeling aspects for labeling development and target labeling for new products.

• Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical safety market access commercial medical affairs) to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products.

• Lead target labeling development.

• Collaborate with functional areas to provide labeling input relevant to clinical study protocols and ensure alignment on endpoints and Patient-Reported Outcomes (PROs) with a label-as-driver approach.

• Provide strategic labeling advice for local labeling in major markets.

• Analyze relevant competitor labeling leverage labeling guidance and trends to develop labeling strategy and content including risk and mitigation identification and assessment.

• Lead Health Authority (HA) labeling strategy discussions and development of contingency labeling plans and content.

• Lead the development revision review agreement and maintenance of target labeling primary labeling (Company Core Data Sheet (CCDS) United States Package Insert (USPI) and associated patient labeling European Union Product Information (EUPI) and derived documents) for assigned compounds.

• Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions leading to development of target and primary labeling.

• Represent global labeling in Global Regulatory teams and other cross-functional teams as appropriate.

• Present at governance meetings such as Labeling Committee to seek endorsement of labeling.

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

• Support global labeling inspections and audits for assigned products as applicable

• This role may collaborate with external partners.

Qualifications:

• A minimum of a Bachelors degree in a scientific discipline is required. Advanced degree (Masters PhD PharmD) in a scientific discipline is preferred.

• A minimum of 8 years of professional work experience is required.

• A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.

• Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.

• 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 application for guidance for labeling is required.

• Experience leading project teams in a matrix environment is required.

• Experience leading continuous improvement projects is required.

• Experience working with document management systems is required.

• Experience effectively/appropriately prioritizing and managing multiple products and projects 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 collaborative customer-focused learning culture is preferred.

The anticipated base pay range for this position in U.S. locations is $137000 to $235750.

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 corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys 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 Companys 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

For additional general information on company benefits please go to: 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.

This job posting is anticipated to close on February 11 2025. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson 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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning Business Writing Fact-Based Decision Making Industry Analysis Legal Support Mentorship Organizing Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Risk Compliance Strategic Thinking Technical Credibility

The anticipated base pay range for this position is :

$137000.00 - $235750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).


This position is eligible to participate in the Companys long-term incentive program.


Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

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

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year


For additional general information on Company benefits please go to: - Experience:

Director