Publishing Specialist

Job Title: Publishing Specialist

Job Description:

Primary responsibility

Supporting end to end Global Publishing support for initial IND/NDA/MAA applications and Lifecycle maintenance of all applications.

Collaborate with various department for planning, preparation, publishing and quality control checks of global submissions.

Performing Lead role as point of contact for the assigned product.

Publishing of eCTD submissions which includes formatting, hyperlinking and Bookmarking.

Strong in working on Adobe acrobat documents as per agency requirements.

Developing and maintaining up-to-date knowledge of established agency standards and procedures for regulatory submissions

Support eCTD, NeES/eSub and Paper submissions format

Troubleshoot document issues with Adobe Acrobat & MS Word and identify gaps in the submission to get address with the respective client stakeholders

Manage technical aspects for assigned submissions and status updates

Perform quality checks on the published outputs, ensure no unacceptable warnings and validation errors before the submission with HA

Perform on the job trainings to follow train the trainer model for beginners/ fellow colleagues and provide QC feedbacks for continuous improvements

Provide feedbacks to clients on the SOP’s/ process improvisations to achieve quick turnaround deliverables and immediate effort efficiencies to client

Qualifications: Graduate/Post-Graduate with a life sciences degree (Preferably Pharmacy or any life sciences domains or equivalent)

Experience and Skills:

5 to 7 years’ experience working in regulatory affairs and strong analytical skills

Significant 'Hands on' experience in creation of submission output for eCTD, NeES, Paper submissions

Needs to be independent performer to manage submission timelines with 100% quality delivery

Proven ability to successfully understand the submission and agency requirements

Effective coordination with cross functional teams in receiving, tracking the documents, addressing the gaps for effective project execution

Highly experienced in Initial IND/ NDA/ MAA submissions as well as Life Cycle Management submissions with tight turnaround time and achieved with first time right time submissions with zero HA rejection.

Proven experience in working on Initial submissions to be delivered to global agencies.

Proven strength in logical, analytical and writing ability is essential

Tool Experience: Veeva Vault, Lorenz, Insight Publisher, , eCTD express, Extedo

Role open for EST and PST time zone