Lead Associate, Publisher

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose - the relentless pursuit of a world that works better for people - we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Lead Associate, Publisher!

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

Qualifications we seek in you!
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

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. Get to know us at and on , , , and .

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a %27starter kit,%27 paying to apply, or purchasing equipment or training.