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Communications Manager, Contract, Switzerland

Eingestellt von Michael Bailey Associates - Zurich

Gesuchte Skills: Client, Consultants

Projektbeschreibung

Start Date:17st Oct 2016

End Date: 31st Aug 2017

Location: Basel

Language: English

Job Title: Translation Manager

Manages the process required for providing the translations (25 languages) of key product information documents (prescribing information, patient leaflets, packaging texts) for products approved in the EU via the centralised procedure (CP) or, occasionally, via the mutual recognition procedure (MRP) and undergoing referral. The process is subject to strict timelines and the translations undergo rigorous review by the regulatory authorities of the EU member states.

Is fully familiar with the official guidance of the EMA (EU regulatory authority) relating to CP/MRP referral translation activities and interacts with a range of partners - translation manager colleagues, DRA (Drug Regulatory Affairs) colleagues in the EU affiliates, DRA product managers, EMA, etc. - to ensure appropriate planning, determine/advise on strategy, communicate timelines and other procedural matters, give guidance on language-related requirements, etc.

Performs quality control of English source documents, ensuring compliance of formatting and terminology with EMA requirements

Issues translation requests, often with detailed instruction sheets, and performs quality control of incoming translations (completeness, compliance with EMA requirements, use of required terminology, etc.), liaising with translators to ensure a high-quality end document. Acts as point of contact between translators and in-house experts on issues of terminology, comprehension, etc. Submits translations to EMA and national regulatory authorities in accordance with strict procedures and manages the feedback received, ensuring that HA-requested revisions are implemented by translators.

Releases final translations to the Artwork Operations (AwOps) group for preparation of printed packaging materials for launch on the EU markets, giving detailed instructions as necessary. Monitors and approves/rejects proof corrections requested by affiliates.

Ensures appropriate document version control and archiving.

Updates LS Sharepoint site for CP translations as required.

We welcome applications of consultants who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.

We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.

Key Words: Communication Manager, translation manager, EMA, DRA, Languages, Contract, Switzerland

Kind regards,

Serena Edith Alpi

Michael Bailey Associates

Job code: 111720

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    10 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Michael Bailey Associates - Zurich