Lead Consultant, Publishing

Job Description

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We&rsquore harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we&rsquore calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing., People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Welcome to the relentless pursuit of better.

We are inviting applications for the role of Lead Consultant, Publishing

In this role, you will work on ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.

Responsibilities

The Role demands for a guide Publisher with proven ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to

. Performing final technical quality review and technical validation (eCTD/NeeS) for US, LATAM and Canadian Submissions.

. Performing final technical quality review and technical validation (eCTD/NeeS)

. Dispatching submission to the meaningful authority (eCTD, NeeS, paper) or affiliate so that affiliate can dispatch to authority

. Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt capturing and the electronic receipt and metadata in RIM presenting submission receipt to key partners

. Collecting submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.

Qualifications we seek in you

Minimum qualifications

. B. Pham/Science Graduate

Preferred qualifications

. Excellent written and verbal communication skills

. Proficient in MS Office applications, especially in MS excel