Job Description

With a startup spirit and 115,000 + curious and courageous minds, we have the expertise to go deep with the world\xe2\x80\x99s biggest brands\xe2\x80\x94and we have fun doing it! We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are 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 are 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.

Inviting applications for the role of Technical Associate
Relevant years of experience and have good knowledge of ICH guidelines and CTD Structure & experience on Publishing Tools like Liquent, Docubridge, etc. will be helpful
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 & performing final technical quality review.
• Dispatching submission to the relevant authority 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.

Requirements

• 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

Qualifications
Minimum qualifications
B. Pham/Science Graduate
Preferred Qualifications / Skills
Pharmacy
Location
Mumbai
Shift
US Shift (5.30 pm-1.30 am)/flexible
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. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
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 \'starter kit,\' paying to apply, or purchasing equipment or training.

Genpact