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Management Trainee - CMC PA Changes

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.
Are you the one we are looking for?

We are inviting applications for the role of MT, CMC PA Changes

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

Responsibilities

The Role demands a specialist 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 acknowledgment from the authority of submission receipt; capturing and the electronic receipt and metadata in RIM; presenting submission receipt to key partners;
  • Capturing 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
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.

Job: Lead Associate

Job ID: CPG016491

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Jul 14, 2020

Master Skills List: Operations

Job Category: Full Time