Proof-Reader, Global Labeling (Temporary/NJ).794-3722
- Job Title
- Proof-Reader, Global Labeling (Temporary/NJ).794-3722
Global pharmaceutical company seeks a Proof-Reader, Global Labeling on a temporary, long term base. This position is hybrid, on-site in North NJ 2-3 days per week and is expected to last 12 months, possibly longer. The hourly rate is $25-$30.The Proof-Reader, Global Labeling will report to the Head of Global Labeling. This role will 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. Additional duties include:
- 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.
- 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.
- 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 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.
- 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.
Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all applicants will receive consideration for employment without unlawful discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.