argenx is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates - tailored from discovery through development to address patient needs.
Purpose of the position: Within regulatory affairs and in cross-functional teams, the global labeling strategist leads global labeling strategy and authoring of products labeling in early development and in post-marketing, including but not limited to Target Product Label, Company Core Data Sheet, Core Instruction for use, prescribing information (PI), patient information, mock-ups and other labeling documents.
Location: US or EU
Key Accountabilities/Responsibilities: Lead labeling strategy in cross functional teams based on target product profile, competitor review, regulations, development data and present it to the development governance for endorsementCreate and maintain target product profile for new assets from phase 2 until registrational phase and for new indication of registered asset(s)Create and maintain Core Company Data Sheet and, in partnership with Labeling Operation Manager, global labeling implementation planSupport US affiliate in USPI creation and maintenanceCoordinate global labeling impact assessment of HA or internal queries of local label update in post-marketing, involving:Labeling working group (LWG) - Cross functional team which members are identified in function of topics among Development team, Project team, Pharmacovigilance, Regional regulatory leads, medical affairs, Regional/local business, Legal representatives, Intellectual property, CMC, supply chain.Global labeling committee (GLC) to endorse LWG proposalSupport affiliates or regulatory partner in geographical expansion including local dossier preparation post CCDS update, definition of strategy to respond to health authority questionsSupport Labeling Operation Manager and Regulatory Operations in regulatory dossier publishingEnsure, in partnership with Labeling Operation Manager, continuous labeling compliance worldwide between CCDS and local PIs during product life cycle and deviation managementProvide labeling contribution to PSUR, RMP and other regulatory procedures as neededCreate and maintain procedures or equivalent related to labeling activity Desired Skills and Experience:
Prior experience in biologic products, medical devices, combined productsPrior experience in clinical development and/or regulatory affairs environmentStrong understanding of labeling end-to-end process and interfaces between Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory, Quality and Supply Chain to ensure complianceKnowledge of US, EU, Japanese labeling templates and labeling sections of eCTD dossierKnowledge of health authority websites (in particular FDA, EMA websites) to retrieve label precedents and labeling regulationsKnowledge of electronic tools such as Dr evidence/Doc label, Adobe Acrobat Pro, Regulatory information management systems, Electronic Document Management System (e.g. Veeva Vault), other tools for labeling quality control (Text Verification Tool).Detail oriented and well organizedGood oral and written English language skillsActive listening, understanding constraints from other disciplineCritical thinking: using logic and reasoning to identify the strength and weaknesses of alternative solutions, conclusions or approached to problemsActive learning: understanding the implications of new information for both current and future problem-solving and decision-makingAnalytical skills: decision taking based on facts and figures rather than on assumptionsTeam player who seeks to help and learn from colleaguesHigh learning attitude and adaptabilityAt least Bachelors DegreeAt least 2 years of experience in global labeling strategy or 5 years in global regulatory affairs
PDN-9d6dbe77-f9d9-42ea-ad77-87ef05a89a00