Sr. Scientist-Global Labeling Lead

Scorpion Therapeutics

North Wales (Montgomery County)

Hybrid

USD 140,000 - 210,000

Full time

14 days+
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Job summary

Scorpion Therapeutics is seeking a Senior Scientist, Global Labeling Lead to develop and maintain compliant labeling content for development and marketed biopharma products, including US and EU labeling.

You will lead cross-functional teams, provide strategic labeling guidance, and act as the regulatory labeling contact for global submissions, shaping labeling strategies for regulatory authorities.

Qualifications

  • Bachelor's level degree in a scientific or medical field.
  • 3+ years in labeling or pharmaceutical industry with leadership of cross-functional teams.
  • Strong understanding of regulatory labeling standards and scientific concepts.
  • Proven project management and communication skills.

Responsibilities

  • Lead cross-functional teams to create, review, and approve labeling.
  • Provide labeling expertise and strategic guidance.
  • Serve as regulatory labeling contact for global submissions.
  • Develop labeling strategies and language for regulatory authorities.

Skills

Labeling expertise
Cross-functional leadership
Regulatory submissions
Project management
Communication

Education

Bachelor's degree in a scientific or medical field

Job description

Role: Senior Scientist, Global Labeling Lead, responsible for developing and maintaining compliant labeling content for development and marketed biopharma products, including Core, US, and EU Labeling. Objectives: ensure high-quality, regulatory-compliant labeling documents to support safe product use globally.

Responsibilities:
  • lead cross-functional teams to create, review, and approve labeling;
  • provide labeling expertise and strategic guidance;
  • serve as the regulatory labeling contact for global submissions;
  • develop labeling strategies and language for regulatory authorities.
Requirements:
  • Bachelor's in a scientific or medical field;
  • at least 3 years of relevant labeling or pharmaceutical industry experience, with experience leading cross-functional teams;
  • strong understanding of regulatory labeling standards and scientific concepts;
  • project management and communication skills.
Preferred:
  • advanced degree (M.S., Pharm.D., Ph.D.),
  • experience with regulatory submissions and global labeling standards.
High-Value:
  • focus on biopharmaceutical products in development or marketed, with a global regulatory scope, supporting regulatory submissions in US and Europe.
WorkSetup:
  • hybrid; travel approximately 10%.
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