Quality - Clinical Labeling Specialist

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 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 checks 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 labeling 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. #J-18808-Ljbffr TechDigital Group