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Management Trainee - CMC PA Changes @ Genpact India

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 Management Trainee - CMC PA Changes

Job Description

* 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 youMinimum 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. ,

Employement Category:

Employement Type: Internship
Industry: IT - Software
Role Category: Training & Development
Functional Area: Not Applicable
Role/Responsibilies: Management Trainee - CMC PA Changes

Contact Details:

Company: Genpact India
Location(s): Mumbai

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₹ 3.5 - 6 Lakh/Yr

Genpact India

Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and ...

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