Lead Consultant - Publisher @ Genpact India

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Lead Consultant - Publisher

Genpact India
2 to 6 Yrs
Mumbai
4 years ago
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Job Description

Lead Consultant, Publisher

The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
Responsibilities
Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and 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 acknowledgment 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
Qualifications we seek in you
Minimum qualifications
B. Pham/M.Pharm/Science Graduate
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
Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.
Preferred Qualifications
Proven rich experience in Pharmacy Regulatory Affairs

Employement Category:

Employement Type: Full time
Industry: IT - Software
Role Category: Medical Transcription
Functional Area: Not Applicable
Role/Responsibilies: Lead Consultant - Publisher

Contact Details:

Company: Genpact India
Location(s): Mumbai

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Designation / Expected Role

Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

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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 ...

Lead Consultant - Publisher @ Genpact India

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