Our client, a leading pharmaceutical company, is hiring a Clinical Labeling Specialist on a contract basis.
New Brunswick, NJ – 100% on-site
Onsite full-time during training period with option to work 50% from home after completion of training.
- Bachelors degree or equivalent in pharmacy, engineering, business or life sciences
- 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.
- 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 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. 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.