Athsai · 12 hours ago

Global Labeling Strategist

California, United States

Contract

Remote

Mid Level

£50/hr - £50/hr

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IT Services and IT Consulting

Hiring Manager

Upma Ghai CertRP

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Responsibilities

Looking for Core labelling strategist activities

Products from development stage (phase 3 product)

Majorly – oncology

Labelling managers need to draft DCDS and CCDS

LM – need to attend all LWG and Labelling Review Committee meeting

Key words – CCDS, core labelling, clinical, strategy pre-clinical, medical, oncology, United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC)

Qualification

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Core labellingDCDS draftingCCDS draftingOncologyClinical strategyPre-clinical strategyMedical writingUSPI knowledgeEU SmPC knowledge

Required

Core labelling strategist activities

Experience with products from development stage (phase 3 product)

Experience in oncology

Ability to draft DCDS and CCDS

Attendance at all LWG and Labelling Review Committee meetings

Familiarity with CCDS, core labelling, clinical strategy pre-clinical, medical, oncology, United States Package Inserts (USPI), and EU Summary of Product Characteristics (SmPC)