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Full-time Project Manager - Labelling

at Cynet Systems in United States Of America

JOB DESCRIPTION
Monitor and develop continuous improvement proposals on the processes
Maintain a staff of adequately skilled resources to meet deliverables
Communicate issues and resolve them in an appropriate time frame
Ensure adherence to agreed-to work practices
Meet established submission timelines and quality standards.
Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labeling
Ensure collection of metrics
Improve speed to minimize the cost
Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions

MINIMUM QUALIFICATIONS:
Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives
Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required
Must be able to construct a Company Response (MAH response) for health authority questions
Masters in Life Sciences
Understanding of key regulatory and Labeling principles and SOPs
Reference : Project Manager - Labelling jobs


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Published at 19-03-2022
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