Technical Associate - Publisher

Genpact

0 - 3 years

Mumbai

Posted: 21/05/2025

Job Description

Responsibilities

Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian Submissions.
Performing final technical quality review.
Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;
Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.

Minimum Qualifications

B. Pham/M.Pharm/Science Graduate
In depth working knowledge of ECTD types of submission, industry standard publishing systems.
Effective time management and organizational skills
Effectively communication
Flexibility to adapt to a changing environment
Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.

Preferred Qualifications
Experience in Pharmacy Regulatory Affairs

About Company

Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.