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Assoc Labeling Specification Spec

Lafayette or North Haven, CT 80026 or 06473

Posted: 01/18/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 598149 Is job remote?: No Country: United States

Job Description


Target PR: 30-33.75 depending on experience

HM's Top Needs:
  1. Medical device labeling experience would be ideal, especially experience with the European MDR requirements
  2. Project Management/ coordination
  3. Label Printing systems & software

Education Required: Bachelors Degree

Years’ Experience Required: 3-5 years

 

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 ndash from design to implementation - while and adhering to policies using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope typically smaller less complex projects or related activities.

Innovation and Complexity: Identifies defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems .

Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather confirm and convey information.

Leadership and Talent Management: N / A ndash job at this level is focused on self-development .

Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree .
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