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Labeling Specification Spec

Sherwood Forest, CA 91325

Posted: 02/12/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 598724 Is job remote?: No Country: United States

Job Description


HM's top needs:
  1. Previous CAPA management/support in another company (familiarity with CAPA quality structure/requirements)
  2. Root Cause Analysis
  3. Process analysis/development

Education Required:

Years’ Experience Required: 1-2 years Minimum

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes 50hr/week

Work Location:

                Do they need to be local to any MDT office and if so where? Local to Northridge preferred but not required

Does this person need to be on site? If so, full time or part time? If local, contractor will work Flex (onsite 3 days/week)

Responsibilities may include the following and other duties may be assigned.
  • Creates, reviews, and reproduces text required for labeling medical products.
  • Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements.
  • Monitors changes in labeling regulations in the US and/or abroad.
  • Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.
  • Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools and/or policies.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information status needs and issues in order to inform gain input and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience or advanced degree with 0 years of experience.
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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