Global Labelling Strategist

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 discipline
• Critical thinking: using logic and reasoning to identify the strength and weaknesses of alternative solutions, conclusions or approached 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)