Manager - Publishing

Job Description

Job description :

• Lead a high preforming team of Submission publishers
• Responsible for delivering and driving high quality submissions by self and the team in compliance with technical requirements from regulatory authorities.
• Responsible for fixing / guiding the team to fix / resolve any errors / challenges / roadblocks to ensure quality output to the HA u2013 Submissions troubleshooting
• Drive first time right approach by educating the team and upstream workstreams on the relevant activities
• Collaborate with other Operations team / other relevant stakeholders to work towards a common goal and drive and deliver quality outputs
• Work closely with the team to Identify value adds / process improvements in the process and deploy the same for efficiency gain
• Proactively work with the team to identify gaps / errors and liaise closely with the affiliates / Regional leads / any relevant key stakeholders to close the same through offering solutions
• Work on work load versus resource mapping for an optimized resource management
• Manage the Publishing workflow to acknowledge and deliver timely submissions to key stakeholders
• Awareness, equip and adaptation of self and the team to all the change in regulations across the countries
• Actively involved in testing and documentation of any new implementations or upgrades of the tools used in the organization
• Train the team and also the end user through train trainer program on the systems for Publishing suite
• Optimize the cost of tickets through screening for any end user related mistakes before raising the ticket
• Be actively involed in tecnical discussions with ArisG for Publishing related queries to suggest or challenge on feature functionalties of Publishing suite
• Conduct or actively contribute towards kick off meetings of eCTD implementation in a new country
• Actively involved in career development planing and execution and competency development
• Involved in hiring and onboarding any new talent
• Performance evaluation of the team members

Technical Competency and Development

Minimum Experience / Training Required :

A minimum of 10-12 years of experience in Submission publishing, Regulatory Affairs with atleast 5-6 years of people management and team handling experience.

Skills Required

Resource Management, Process Improvements