Join to apply for the Associate Director, Global Labeling Product Leader role at Johnson & Johnson Innovative Medicine
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.
Job details and locations
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
All Job Posting Locations:
* Beerse, Belgium
* Antwerp, Belgium
* Warsaw, Poland
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).
* United States - Requisition Number: R-029419
* Belgium, Poland - Requisition Number: R-030560
* United Kingdom - Requisition Number: R-030563
* Switzerland - Requisition Number: R-030568
Note: applications may be considered as a single submission.
Role summary
Johnson & 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 Beerse, Belgium or Warsaw, Poland.
Responsibilities
* Drive the global labeling strategy, including understanding competitors in the therapeutic area, their development plans, and labeling considerations for labeling development and target labeling for new products.
* Lead with Global Regulatory Leads (GRLs) and other functional area partners to align the global labeling strategy with Global Regulatory and Product Strategy for assigned products.
* Lead target labeling development.
* Collaborate with clinical, safety, market access, commercial, medical affairs and other functions 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 competitor labeling and use labeling guidance and trends to develop labeling strategy and content, including risk and mitigation planning.
* Lead Health Authority (HA) labeling strategy discussions and development of contingency labeling plans and content.
* Lead development, revision, review, agreement, and maintenance of target and primary labeling (CCDS, USPI, EU Product Information, and derived documents) for assigned compounds.
* Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions to develop 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 on 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 and compliant labeling documents.
* Contribute to continuous improvement of end-to-end labeling processes.
* 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 is required; advanced degree (Master’s/PhD/PharmD) preferred.
* Minimum 8 years of professional work experience required.
* Minimum 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent required.
* 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.
* Good understanding of worldwide regulatory guidelines for labeling required.
* Experience leading project teams in a matrix environment required.
* Experience leading continuous improvement projects required.
* Experience working with document management systems required.
* Ability to prioritize and manage multiple products and projects; preference for those with broader experience.
* Exceptional verbal and written communication skills required.
* Strong organizational, negotiation, and partnering skills required.
* Ability to work independently.
* Ability to manage compounds with complexity from a labeling perspective preferred.
* Ability to drive a collaborative, customer-focused, learning culture preferred.
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Product Management and Marketing
* Industries: Pharmaceutical Manufacturing
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