Regulatory Proof Reader
A well-known international pharmaceutical company with sites around the globe is looking to hire a Regulatory Proof Reader. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
- Provide document verification proofing of packaging and labelling artwork versus Editor's Copies (EC's) to assure compliance with required local country (and/or regional) format and style guidelines.
- Evaluate packaging and labelling artwork updates, interpret information and ensure that changes have been applied consistently across products and product lines.
- Initiate discussions with ALIM Market Coordinators or the company's artwork centres/plants when inconsistencies are discovered.
- Annotate packaging and labelling artwork using digital tools. Use appropriate judgment and approve or reject packaging and labelling artwork.
- Provide a clear explanation of the company's artwork centre for accurate re-creation of artwork when needed.
- Monitor individual document verification proofing workload and ensure ALIM meets agreed upon the company's artwork Request timelines.
- Provide editorial comments for regulatory documents prior to the creation of artwork by companies sites to GLMs and/or WRS if requested.
- Escalate issues and initiate discussions with ALIM Market Coordinators (or GLM Hub Labeling Managers, etc.) to drive consistency within and across labelling documents.
Skills and Requirements:
- Bachelor's degree plus 2 years experience.
- In proofing pharmaceutical labelling, packaging components or medical/scientific documents.
- 4+ years of experience in pharmaceutical proofreading may be considered in lieu of degree.
- Strong editing/proofreading skills, including broad vocabulary and knowledge of medical/scientific terminology.
- Attention to detail and ability to focus attention for long periods of time.
- Robust text comprehension and ability to identify and mark errors in typography, spelling, word usage, style, punctuation and grammar.
- Ability to apply these skills across multiple languages, especially non-native language is highly desirable.
- Ability to use mechanised and electronic proofreading tools such as vision systems and comparators. Excellent interpersonal, organisation and communication skills.
- Flexible and capable of prioritising projects, meeting deadlines and working well under pressure.
- Must be able to work effectively with frequent reading, which may cause eye strain. 20/20 colour vision (corrected) is required.
- Non-standard work schedule, travel or environment requirements
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Elise Stewart at 0207 440 0633 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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