Description
Primary Responsibilities:- Works with the Labeling Operations Specialist and Above Country strategist to obtain the internally approved EN label, submission type and summary of changes.
- Ensures that all labeling translation jobs initiated within GDMS have been picked up by the designated Labeling Translations Vendor and that the resulting translations are delivered per the agreed timeframes.
- Monitors internal tracking systems to ensure that the status of every labeling translation is visible and overseen through to completion and entered into the correct location in the companies document management system.
- Suggests/advises the team which label translations should occur 'at risk', liaises with the Translations vendor to progress the translations accordingly, and troubleshoots vendor issues as required.
- Work with other translation coordinators to ensure all product activity adequately covered.
- Takes responsibilities for the Translations mailbox, maintenance and archiving.
- Suggest process and training improvements for translations either via experience or feedback from stakeholders and revises necessary documents as required.
- Ensures CHMP opinion is communicated to PCOs and the Translation Vendor so that the appropriate actions are taken and deadlines are re-confirmed.
- Proactively manages Vendors as due dates get nearer so that potential delays can be eliminated.
- Understands PDF & Bookmarking requirements.
- Builds expertise and knowledge in CP and MRP translations to become SMEs for stakeholders.
Essential:
- Degree in Pharmacy, Life Sciences, Business or Information Technology
- Strong working knowledge of word, excel, and project management tools; experience/aptitude in project management
- Demonstrated ability to multi-task in a fast-moving environment while meeting strict deadlines
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
- Attention to detail; ability to work with accuracy; adaptable to changing priorities
- Demonstrated attention to detail
- Multi-lingual skills would be highly desirable
- Knowledge of drug development process; Familiarity with pharmaceutical organizational structures, systems, and culture is preferred
Sthree UK is acting as an Employment Business in relation to this vacancy.