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Global Labeling Manager

Eingestellt von Coopers Group GmbH

Gesuchte Skills: Support, Oracle, Citrix, Client

Projektbeschreibung

For our Pharma client in Basel we are currently looking for a

GLOBAL LABELING MANAGER

TASKS AND RESPONSIBILITIES

- Manages core labeling documents (health care professional information and patient information leaflet) for assigned products in order to present all relevant data concerning a particular product in a comprehensible form to enable the different countries to produce, based on these, their HCP information and their patient information leaflet
- Perform timely creation of CCDSs for development products (NPDs) and manage their maintenance for marketed products, observing legal regulatory requirements and taking into account for the current medical and scientific knowledge in close co-operation with the relevant expert functions
- Manages cross-functional expert teams for the assigned clients products which jointly discuss the latest results and potential signals relevant to the products and their possible inclusion in the core labeling documents
- Providing input to Regulatory Submission Strategies from labeling point of view.
- Ensures availability of up to date labeling documents and related documents in a global labeling database
- Coordination and contribution to/conducting the evaluation of local labeling deviations in order to monitor harmonization of the clients world-wide product information.
- Initiation of corrective measures where possible and analyzes the possible impact of deviations on the core labeling documents.
- Consistently and properly escalates noncompliance issues according to Governance processes
- Support and educate experts, regional functions and affiliates with regard to labeling issues incl legal requirements and labeling guidelines and support regions/affiliates in the implementation of the CCDSs into local labeling documents

QUALIFICATIONS

- University Degree in Pharmacy, Regulatory Affairs, or Life Sciences.
- At least five years of experience in a role within the pharmaceutical industry (preferably within R being familiar with use of databases (eg Citrix-based, Oracle-based)

START: 07.01.2019
DURATION: UNTIL SEPTEMBER 2019
LOCATION: BASEL

Are you interested to work in this challenging position? Alessia Biassoli, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail (see below)

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Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    30.09.2019

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Coopers Group GmbH

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