Posted:1 day ago|
Platform:
On-site
Full Time
.Monitor and develop continuous improvement proposals on the processes.
.Maintain a staff of adequately skilled resources to meet deliverables.
.Communicate issues and resolve 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 labelling
.Ensure collection of metrics required by the client
.Improve speed to the client and minimize cost to the client
.Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
.Demonstrated knowledge and understanding of CCDSs, US and EU labelling, and the dynamics of Labelling 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
.Understanding of key regulatory and Labelling principles and SOPs
.Masters in Life Sciences
.Should be open to work in any shift as per the business requirement
.in 140,000+ bold thinkers and problem-solvers who push boundaries every day
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