Quality - Clinical Labeling Specialist - TechDigital
New Brunwick, NJ
About the Job
This position will require person to be onsite full-time during training period with option to work 50% from home after completion of training.
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 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.
Education:
Bachelors degree or equivalent in pharmacy, engineering, business or life sciences
Skills Required
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
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 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.
Education:
Bachelors degree or equivalent in pharmacy, engineering, business or life sciences
Skills Required
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
Source : TechDigital
