Abbott - Publishing Manager

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 - 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 planning and execution and competency development

- Involved in hiring and onboarding any new talent

- Performance evaluation of the team members

- Technical Competency and Development

- 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