Overview

Johnson & Johnson Innovative Medicine is recruiting for the role of Associate Director, Global Labeling Product Leader. This hybrid role will be located in High Wycombe, United Kingdom.

Our goal is to deliver breakthroughs in healthcare and support patients every step of the way. Learn more at https://www.jnj.com

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 https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

All Job Posting Locations

• United States - Requisition Number: R-029419
• Belgium, Poland - Requisition Number: R-030560
• United Kingdom - Requisition Number: R-030563
• Switzerland - Requisition Number: R-030568

Note: The posting location for the role is High Wycombe, Buckinghamshire, United Kingdom. This is a hybrid position.

Responsibilities

• Drive the global labeling strategy, including understanding competitors in the therapeutic area, their development plans and status, and labeling implications for labeling development and target labeling for new products.
• Lead with Global Regulatory Leads and other functional area partners to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products.
• Lead target labeling development.
• Collaborate with clinical, safety, market access, commercial, and medical affairs to provide labeling input relevant to clinical study protocols and ensure alignment on endpoints and Patient-Reported Outcomes, with a label-as-driver approach.
• Provide strategic labeling advice for local labeling in major markets.
• Analyze competitor labeling, leverage labeling guidance and trends to develop labeling strategy and content, including risk and mitigation identification and assessment.
• Lead Health Authority labeling strategy discussions and development of contingency labeling plans and content.
• Lead the development, revision, review, agreement, and maintenance of target labeling and primary labeling documents (CCDS, USPI, EU Product Information, and derived documents) for assigned compounds.
• Lead cross-functional Labeling Working Group 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 (e.g., Labeling Committee) to seek endorsement of labeling.
• Provide advice and guidance about labeling content, processes, timelines, and scientific integrity; coordinate resolution of labeling issues with potential impact on primary or derived labeling and supporting documentation; ensure high quality, compliant labeling documents.
• Contribute to 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

• Bachelor’s degree in a scientific discipline required; advanced degree (Master’s, PhD, PharmD) preferred.
• Minimum of 8 years of professional work experience.
• Minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent.
• Direct experience with target labeling development or New Molecular Entity (NME) submissions preferred.
• Relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) required.
• Understanding of pharmaceutical drug development required.
• Experience in discussing and communicating scientific concepts required.
• Strong understanding of worldwide regulatory guidelines and their application for labeling guidance.
• Experience leading project teams in a matrix environment required.
• Experience leading continuous improvement projects required.
• Experience working with document management systems required.
• Experience prioritizing and managing multiple products and projects simultaneously preferred.
• Exceptional verbal and written communication skills.
• Strong organizational, negotiation, and partnering skills.
• Ability to work independently.
• Ability to manage compounds with a certain degree of complexity from a labeling perspective preferred.
• Ability to drive a collaborative, customer-focused, learning culture preferred.

Job Details

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Product Management and Marketing
• Industries: Pharmaceutical Manufacturing