Clinical Labeling Operations

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. Job Description Essential Functions: Responsible for the coordination of new clinical labeling implementation with Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chaing Labeling BPO, PM s and multiple packaging sites worldwide. Creates labels content and maps content to the appropriate fields in Bartender. Creates Business Continuity Labels and maps contents to the appropriate fields. Reviews clinical final product label content and Bartender mapping to ensure all content matches source documents and text is mapped to the appropriate fields. Liaises with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met. Manages the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience. Authors standard operating procedures, guidelines and work instructions. Collaborates with team members to meet departmental goals and objectives. Completes labeling updates as assigned. Knowledge, Experience and Skills: Highly capable at directing and coordinating project work. Strong verbal, technical writing and interpersonal skills. Proficient in Microsoft Office applications. Knowledge of FDA and cGMP standards as well as regulatory guidance documents. Prior experience in pharmaceutical or other regulated industry is required. Prior experience in clinical or commercial supply chain. Familiarity with artwork/labeling production. Familiarity with Bartender software is bonus. 6+ years of relevant experience and a BS or BA or 4+ years of relevant experience and a MS. TekWissen Group is an equal opportunity employer supporting workforce diversity. #J-18808-Ljbffr TekWissen ®