Job Number: 25545079
Pay Rate: 54.01-55.16 USD/Hour
CLINICAL LABELING SPECIALIST
NEW BRUNSWICK, NJ
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.
- 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.
- 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
ALPHA'S REQUIREMENT #23-01752
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE