Assoc Labeling Specialist

  • location: Irvine, CA
  • type: Contract
  • salary: $25 - $29.53 per hour
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job description

Assoc Labeling Specialist

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Irvine, California
job type: Contract
salary: $25.00 - 29.53 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Ensure appropriate and necessary labeling to meet regulatory requirements, with focus on sustaining products.
  • Assist in the development of solutions for labeling projects, involving: legacy systems, country-specific requirements, and product performance updates in collaboration with business unit labeling managers
  • Technical Editor for activities that establish labeling content and instructions for use labeling; including evaluating information input into system to determine necessary content for use in labeling.
  • Follow and maintain timetables for creating new/revised content and labeling in a cost-effective manner
  • Identify risk and may propose new alternatives to resolves critical issues
  • Participate in process improvement projects
  • Other incidental duties, including working with different suppliers and vendors to propose improvement opportunities, and coordinates pre-press/press proof with printing vendors, as needed.
 
qualifications:
  • Bachelor's Degree or equivalent 3 Years' experience medical/pharmaceutical FDA regulated industry Required
  • Strong computer skills including usage of MS Office Suite; experience with MS Project preferred
  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Strong leadership skills with demonstrated ability to influence change
  • Proven success adhering to and leading project schedules and managing projects
  • Able to read, comprehend, write, and speak English
  • Substantial understanding of domestic and global development and implementation of labeling
  • Substantial understanding of medical and/or pharmaceutical regulations and standards
  • Substantial knowledge of medical device documentation development activities
  • Knowledge of ECR, PDM, and CAPA processes
  • Strong computer skills including usage of MS Office Suite
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Good project management skills
  • Strong leadership skills and ability to influence change
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness
 
skills: CAPA, MS-Project
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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