Global Labelling Strategist
Apply locations: Belgium - Remote, Boston, MA, USA
Time type: Full time
Posted on: Posted 3 Days Ago
Job requisition id: REQ-3251
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, lead the labeling development of one asset, supervise Target Product Label initiative across argenx portfolio and, when needed, contribute to the labeling strategy of other assets.
Key Accountabilities/Responsibilities:
Lead labeling development strategy in cross functional teams based on target product profile, competitor review, regulations, development data and present it to the development governance for endorsement.Create and maintain target product profile for one asset 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 plan.Support US affiliate in USPI creation and maintenance.Coordinate 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, Regulatory leads, Medical affairs, Commercial, Legal representatives, Intellectual property, CMC, supply chain.Global labeling committee (GLC) to endorse LWG proposal.Create and maintain processes related to labeling development activity.Desired Skills and Experience:
Prior experience in biologic products, medical devices, combined products.Prior experience in clinical development and/or regulatory affairs environment.Strong understanding of labeling end-to-end process and interfaces between clinical development, medical affairs, Pharmacovigilance, Regulatory, Quality and Supply Chain to ensure compliance.Knowledge of US, EU, Japanese labeling templates and labeling sections of eCTD dossier.Knowledge of health authority websites (in particular FDA, EMA websites) to retrieve label precedents and labeling regulations.Knowledge 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 organized.Good oral and written English language skills.Active listening, understanding constraints from other disciplines.Critical thinking: using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.Active learning: understanding the implications of new information for both current and future problem-solving and decision-making.Analytical skills: decision taking based on facts and figures rather than on assumptions.Team player who seeks to help and learn from colleagues.High learning attitude and adaptability.At least Bachelor's Degree.At least 5 years of experience in global labeling strategy (development and post-marketing).About Us:
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland.
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