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Internship Global Labeling Lead Jobs (NOW HIRING)

Eisai, Inc.

Senior Manager, Global Labeling

$129K - $169K/yr

The Senior Manager, Global Labeling facilitates and leads the development, review, approval, and ... Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP ...

Eisai

Senior Manager, Global Labeling

$129K - $169K/yr

The Senior Manager, Global Labeling facilitates and leads the development, review, approval, and ... Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP ...

Parexel International

$150 - $190/hr

Parexel is seeking an experienced and highly motivated Global Regulatory Labeling Lead to provide strategic leadership and operational oversight for complex global labeling initiatives. This role is ...

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Internship Global Labeling Lead information

What is the difference between Internship Global Labeling Lead vs Global Labeling Associate?

AspectInternship Global Labeling LeadGlobal Labeling Associate
Required CredentialsCurrently pursuing or recently completed a degree in life sciences or related fieldTypically entry-level, with some background in life sciences or related area
Work EnvironmentInternship setting within pharmaceutical or biotech companies, focusing on labeling projectsSupport role in labeling teams, assisting with documentation and compliance tasks
Employer & Industry UsageUsed in pharmaceutical companies during internship programs for future labeling professionalsCommonly employed as entry-level support staff in labeling departments

The Internship Global Labeling Lead is an internship position aimed at gaining experience in global labeling processes, often involving project support and learning. In contrast, the Global Labeling Associate is an entry-level role focused on assisting with labeling documentation and compliance tasks. The internship is temporary and educational, while the associate role is a foundational position within the labeling team, often leading to further career development.

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Internship Global Labeling Lead jobs near you

Associate Director, Global Labeling Lead

Scorpion Therapeutics

Cambridge, MA • On-site

$150 - $190/hr

Other

Posted yesterday

New

Job description

Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU)Responsibilities:
  • Provide regulatory expertise and strategic guidance to internal stakeholders to develop and maintain pharmaceutical drug/device labeling.
  • Contribute labeling strategy to regulatory strategies; liaise on evolving submission/negotiation plans.
  • Formulate labeling strategies for new/revised prescribing information and packaging; interpret scientific/medical/regulatory data.
  • Advise on labeling requirements, templates/tools, and Health Authority guidance.
  • Drive CCDS/US/EU labeling strategy and lifecycle management; lead development and maintenance of CCDS, US, and EU labels.
  • Prepare labeling vision for early programs; align stakeholders.
  • Lead global labeling teams and cross-functional projects; resolve conflicts/issues with minimal escalation.
  • Support combination product/drug-device labeling; prepare backup strategies for labeling negotiations.
  • Manage labeling processes/tools/systems, project-manage labeling updates to meet timelines, ensure version control/QC, maintain labeling decision records, and deliver labeling training.
Qualifications & Required/Preferred Skills:
  • 7–10 years biopharmaceutical industry experience; 5–7 years direct global US/EU labeling experience desired.
  • Knowledge of EU/US labeling requirements/guidance; combination product/drug-device labeling preferred.
  • Expertise maintaining Core Data Sheet (CCDS), USPI, and EU SmPC; understanding of SPL format for legacy/PLR labels.
  • Proficiency with Electronic Document Management Systems and end-to-end (E2E) labeling tracking systems.
  • Bachelor’s or Master’s required (advanced scientific/health sciences preferred); leadership/management of direct reports preferred.
Location:

Cambridge, MA (Hybrid)

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