Posted to MedZilla on 8/19/2017


ProClinical

England, Regulatory Operations Specialist RA_NS_13144-MZ


 
 

A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Specalist Regulatory Operations . This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK. The Labeling Operations Proofreader is responsible for supporting development and implementation of new and revised printed labeling for assigned products, primarily in a proofreading capacity. Depending on ability, the candidate may also provide other operational support to ensure labeling document integrity and delivery.

Job Responsibilities:

  • Contribute to labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents
  • Assist GRAPSQA Labeling Operations staff in the commercial printed labeling Label Control Coordination activities and other packaging component labeling activities for assigned products
  • Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents.
  • Assist in Content of Labeling/Drug Listing SPL generation and review.
  • As requested, assist in maintaining repository of current labeling documents and with uploading of documents to electronic document management system.
  • Review product labeling galley proofs for the Physician's Desk Reference, as appropriate.
  • Assist Labeling team in resolution of labeling issues as needed.
  • Help ensure regional submission timelines are met.
  • Help ensure corporate quality standards for labeling are met.
  • As requested, participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function.
  • Perform functions with minimal supervision.
  • Assist in other activities as requested.

Skills and Requirements:

  • Bachelor's Degree or equivalent experience
  • Experience in a proofreading capacity
  • Able to multi-task
  • Excellent planning and organizational skills
  • Excellent oral and written communication skills
  • Act quickly in response to management objectives
  • Self-motivated and proactive worker
  • Possess professional ethics
  • Proficiency in the use of Microsoft Word, Excel, Project, Adobe Acrobat and other software programs
  • Strong interpersonal /group skills
  • Capable of working collaboratively with colleagues in all functions. Team player
  • Flexible in changing project priority
  • Exercise good judgment and operate with large degree of independence regarding routine assignments
  • Keen attention to detail and accuracy
  • Communication skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Results Focused - ability to overcome obstacles and achieve key outcomes
  • Cultural Awareness - able to work successfully in a multi-cultural environment
  • Builds effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Ethics - overriding commitment to integrity and high standards in self and others
  • Work experience in a biotech/pharmaceutical arena (preferably in labeling) is highly desirable.
  • Experience working in a GMP pharmaceutical environment preferred.

To Apply:

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 call Numhom Sudsok on +44 203 8718 093 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.


Please visit our website at www.proclinical.com

 
 


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