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Proof-Reader, Global Labeling

Employer
EPM Scientific
Location
Nutley, NJ
Closing date
Sep 23, 2022

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Sector
Other
Organization Type
Corporate
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We have a current opportunity for a Proof-Reader, Global Labeling The position will be based in Nutley. For further information about this position please apply.

Job Responsibilities:
  • Prioritizes tasks and projects according to businesses' needs and turn-around time.
  • Demonstrates advanced proficiency in Microsoft Word and PDFs.
  • Demonstrates strong interpersonal skills. Clearly communicates and collaborates with internal and external partners/teams.
  • Demonstrates experience working within an established brand product.
  • Demonstrates knowledge of GMP and production principles and best practices in the management and coordination of the of labeling documentation.

Responsibilities will include but not be limited to:
  • Ensure labeling for new and existing products are developed and maintained within regulations
  • Follows Good Documentation Practices.
  • Provide labeling support for GL as appropriate
  • Verifies documentation packages (forms and reference documents) for labeling.
  • Confers with document originators or Global Labeling Leads to resolve discrepancies and compiles required changes to documents.
  • Responsible to proofread product labeling and the Company Core Data Sheet.
  • Performs documentation-related functions.
  • Support the update of labeling, and any other labeling component in order to meet current regulatory requirements.
  • Within the project timeline, lead the review of the updates to ensure no discrepancies between the master copy and the formatted proof and that the document meets the requirements per the quality system.
  • Proofreader will support the labeling changes by reviewing content and formatting of documentation, as well as support of any other outstanding activities as required.
  • Performs other duties assigned as needed.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Tools and equipment used / working environment
The Proof-Reader, Global Labelling is expected to possess a strong working knowledge of the proof-reading process, Microsoft Office applications, and project management skills.

Working relationships:
The Proof-Reader will report to the Head of Global Labeling. This individual will be expected to routinely work a global, multidisciplinary environment with such individuals as the Global Labeling Leads, the Oncology and Neuroscience Business Groups, Medicine Development Center, affiliates, partners, Legal, Commercial, and Safety.

Specifications
Qualifications, education and language requirements:
  • Bachelor's degree or higher in Life Sciences
  • Excellent written and spoken English
  • Regulated work industry preferred
  • Minimum of three years of professional-level proofreading experience required

Experience Required:
  • Experience with proofreading
  • Experience in Regulatory, R&D or related area or equivalent experience within the pharmaceutical industry.
  • Knowledge of global regulations, guidance documents, ICH guidelines, and demonstrated ability to apply regulatory guidelines to product labelling.
  • Proven interpersonal skills; negotiating, communicating, & explaining.

Skills and Aptitude Required:
  • Ability to accurately review complex materials, including referencing multiple sources of data with exceptional attention to detail
  • Excellent project management skills
  • Highly organized with the ability to coordinate multiple projects and deadlines
  • Ability to operate effectively in a fast-paced, deadline-driven environment, with the ability to prioritize tasks according to clients' needs
  • Excellent eye for consistency
  • Experience in local and global regulatory environments and work on multiple projects.
  • Be team-oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity- working environment.
  • Able to work under pressure.
  • Scientific background or familiarity with medical terminology and knowledge of FDA regulations and guidance is preferred.
  • Proficiency with document comparison software, Microsoft Office, Excel, Outlook, PowerPoint, SharePoint, and Adobe Professional.
  • A high level of skill in written English, including spelling, grammar, and punctuation.
  • Detail oriented ability to work independently and meet deadlines.
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