Lead Associate, Publisher
Genpact
5 - 10 years
Mumbai
Posted: 11/20/2024
Job Description
Responsibilities
The Role demands for an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to
Publishing and performing technical validation of eCTD submissions for US 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 acknowledgement 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.
Co-ordinate with client/stakeholders
Project Management skills
Requirements
Minimum Qualifications
B. Pham/M.Pharm/Science Graduate
Experience and have good knowledge of eCTD submissions and Structure & Expertise with Publishing Tools like Liquent Insight Publisher, Lorenz Docubridge, Extedo eCTDManager etc.
In depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
Effective time management and organizational skills
Effectively communication
Flexibility to adapt to a changing environment
Preferred Qualifications / Skills
Pharmacy
About Company
Genpact is a global professional services firm delivering digital transformation by putting digital and data to work to create competitive advantage.
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