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Labeling Manager

Eingestellt von Synectics

Projektbeschreibung

The Labeling Manager is responsible for executing the content management of labeling text for assigned products across assigned countries in the Latin America region or Canada. This role is responsible for the production of documents containing label text prior to submission. Where appropriate, the Labeling Manager will seek advice from identified roles when the local labeling text deviates from the core. The Labeling Manager ensures delivery of the draft labeling text according to the target delivery dates and oversees submission to timelines to ensure compliance with the SOP timelines. This role will interface with Global Labeling Leads, regulatory colleagues, authors of supporting documentation, Global/Regional Medical TA Leads, Submissions Specialists and Labeling Operations Specialists in the delivery and management of labeling text through appropriate processes and systems to assure the timely submission and approval of product labeling.

SKILLS:

- 4-7 years advanced Patient Information Labeling required.
- Excellent organizational skills and time management skills
- Demonstrated experience managing high volume of work
- Proficiency in writing and reading English and Spanish/Portuguese.
- Demonstrated experience working with Documentum-based document management system, labeling tracking system, and managing end to end labeling process.
- Knowledge of Latin American regulatory labeling guidelines desirable.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Synectics