Integrated Resources, Inc ( IRI ) Hiring for Clinical Labeling Specialist at New Brunswick, NJ Full Time

Job Title: Clinical Labeling Specialist

Job Location: New Brunswick, NJ (Hybrid)

Job Duration: 12 Months+

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

Pay rate: $47 – $55/hr on W2

Job Description:

Position 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 s 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 exacting 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. s 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.

Education:

• Bachelor’s degree or equivalent in pharmacy, engineering, business or life sciences required

Skill Required

• Ability to plan, manage and execute multiple projects and to deliver aProductst 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