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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. Learn more at https://www.jnj.com
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
All Job Posting Locations: Allschwil, Basel-Country, Switzerland
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 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
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Labeling Product Leader. This position is a hybrid role and will be located in Allschwil, Switzerland.
Responsibilities
* Drive the global labeling strategy, including understanding competitors in the therapeutic area, their development plans and status, and knowledge of labeling aspects for labeling development and target labeling for new products.
* Lead with Global Regulatory Leads (GRLs) and other function partners to ensure the global labeling strategy aligns with 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 (CCDS, USPI, 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 labeling issues with potential impact on labeling, ensuring 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
* Bachelor’s degree in a scientific discipline required; advanced degree (Master’s, PhD, PharmD) preferred.
* Minimum 8 years of professional work experience.
* Minimum 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.
* Good understanding of worldwide regulatory guidelines and their application for labeling guidance 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 effectively prioritize and manage multiple products and projects; preferred.
* Exceptional verbal and written communication skills; strong organizational, negotiation, and partnering skills; ability to work independently.
* Ability to manage compounds with complexity from a labeling perspective; willingness 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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