New Brunswick,
NJ
08903-0191
US
Posted: 10/31/2023
2023-10-31
2023-12-31
Job Number: 25545087
Pay Rate: 46.97-47.97 USD/Hour
Job Description
CLINICAL LABELING SPECIALIST
NEW BRUNSWICK, NJ
This position will require person to be onsite full-time during training period with option to work 50% from home after completion of training.
The pay range for this position is $46.97 to $47.97 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.
- Works with external partners to ensure clinical labels are created with exact specifications.
- 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.
- Minimum 2 years pharmaceutical experience.
- 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.
- Good 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.
- Good 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
ALPHA'S REQUIREMENT #23-01753
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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