Manager - Publishing
- Mumbai, Maharashtra
- Permanent
- Full-time
- 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 – 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 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
- Work as an SME for the team and affiliates in regard to the relevant workstream processes
- Deeper understanding of the of processes across product line – Pharma and Vaccines
- Work towards competency enhancement of the team with constant touch base
- Develop a backup for self to manage any technical queries, develop simplified work guide which will help use the same as reference material
- An expert in e CTD concepts and trouble shooting
- Exposure to markets – RoW (EM), EU, (US - would be good to have)
- Exposure to varied Publsihing tools to idetnify white space and suggest optimization
Mumbai : BKC BuildingADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Not specifiedMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)