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Clinical Labeling Specialist

New Brunswick, NJ 08903

Posted: 10/31/2023 Job Number: 25545079 Pay Rate: 54.01-55.16 USD/Hour

Job Description

This position will require to be onsite full-time during training period with option to work 50% from home after completion of training.

The pay ranges between $54.01 - $55.16 per hour.

Project Description:
  • Supports timely delivery of clinical supplies through effective management of assigned projects.
  • Manages multiple projects and tracks all activities and milestones related to assigned projects. Identifies and reports issues to appropriate levels of management in a timely manner.
  • Generates label vendor specifications in accordance with relevant regulatory requirements for assigned projects.
  • Works with external partners to ensure clinical labels are created with exact specification.
  • Generates clinical labeling source documentation as required.
  • Reviews and approves vendor generated label proofs/specifications and other related documents.
  • Utilizes electronic verification software to perform check on label proof. Routes final label for review and approval accordingly.
  • Participates in assigned training including cGMP and safety training.
  • Ensures regulatory, cGMP, GDP compliance of activities in assigned areas of responsibility. Reports any deviations to the appropriate management.
  • Works cross-functionally with individuals and project teams in various areas
  • Liaises with responsible Trial Supplies Manager on aspects of clinical supplies packaging and labelling design and study requirements and resolves issues.

Required Skills:
  • Bachelor's degree or equivalent in pharmacy, engineering, business or life sciences required.
  • Ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
  • Strong project management skills and detail oriented.
  • Possesses solid oral and written communication skills.
  • Excellent decision making and organizational skills.
  • Ability to effectively communicate ideas and to influence others to achieve results.
  • Ability to understand and apply regulatory and cGMP principles.
  • Thorough understanding of pharmaceutical or medical terminology.
  • Proficiency in standard MS office technology, including Microsoft Suite (Outlook, PowerPoint, Excel) and additional applications such as Adobe. Willing to learn additional applications as needed.
  • Experience working on multi-disciplinary teams and projects.
  • Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.G., revision control) is preferred.

This 12+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com


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Bridget Burns

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