Global Labelling Development Lead

Company: Proclinical Group
Location: Boston
Posted on: April 3, 2025

Job Description:

Proclinical is seeking a Global Labelling Development Lead to guide the labelling development for a key asset and oversee the Target Product Label initiative across our portfolio. Your expertise will also contribute to the labelling strategy of other assets as needed. This position can be based either in East Coast USA, Belgium or Switzerland.Responsibilities:

• Lead the labelling development strategy in cross-functional teams, considering target product profiles, competitor reviews, regulations, and development data.
• Create and maintain the target product profile for one asset from phase 2 to registration and for new indications of registered assets.
• Develop and manage the Core Company Data Sheet and collaborate with the Labelling Operation Manager on global labelling implementation plans.
• Support the US affiliate in creating and maintaining the USPI.
• Coordinate global labelling impact assessments for health authority or internal queries related to local label updates in post-marketing.
• Facilitate the Labelling Working Group and Global Labelling Committee to endorse proposals.
• Establish and maintain processes related to labelling development activities.Key Skills and Requirements:
  • Experience with biologic products, medical devices, or combined products.
  • Background in clinical development or regulatory affairs.
  • Comprehensive understanding of the labelling process and its interfaces with clinical development, medical affairs, pharmacovigilance, regulatory, quality, and supply chain.
  • Familiarity with US, EU, and Japanese labelling templates and eCTD dossier sections.
  • Proficiency in using health authority websites for label precedents and regulations.
  • Skilled in electronic tools like Dr Evidence/Doc Label, Adobe Acrobat Pro, and regulatory information management systems.
  • Detail-oriented, organized, and proficient in English.
  • Strong critical thinking, active learning, and analytical skills.
  • Team player with a high learning attitude and adaptability.
  • Bachelor's degree required.
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Keywords: Proclinical Group, Boston , Global Labelling Development Lead, Other , Boston, Massachusetts