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Senior Manager, Publisher

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. 
 Transformation happens here. Come, be a part of our exciting journey!
Are you the one we are looking for?
Inviting applications for the role of Senior Manager, Publisher!

The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
Responsibilities
•    To manage and deliver end to end submissions for US, Europe, Canada, Japan, EAEU and ROW market in eCTD, NeeS and Paper format
•    Liaison between client and internal project team. Coordinate for routine regulatory submissions
•    Provide timely invoice, project budget and keep visibility of overall financial health of engagement.
•    Manage the team by providing project management, prioritization, direction and leadership to team members in order to accomplish defined project deliverables on given deadlines
•    Leverage subject matter knowledge on business / project implementation issues related to the Regulatory process.
•    Recruit new team members. Mentor for their growth.
•    Conduct Governance with the client and execute metrics compliance in the process.
•    Resolve technical, validation issues and provide guidance to team.
•    Responsible for triaging work to the team to ensure rapid turn-around for high priority jobs.
•    Notifying relevant stakeholders that the Submission is ready for approval
•    Dispatching submission to the relevant authority (eCTD, NeeS, paper) or affiliate so that affiliate can dispatch to authority; 
•    Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence.
•    
Qualifications we seek in you!
Minimum qualifications
•    B. Pham/M.Pharm/Science Graduate  
•    In depth working knowledge of industry standard publishing systems and desktop applications.
•    Expertise with Publisher applications    
•    Effective communication, time management and organizational skills.
•    Trouble shooting 
•    Responsible for triaging work to the team to ensure rapid turn-around for high priority jobs.
•    Flexibility to adapt to a changing environment, 
•    Demonstrated project management and leadership skills. 
•    Skilled at fostering customer relationships and driving collaboration.
•    Understanding of global regulatory processes and requirements.
•    Strong attention to detail, ability to multi-task.
•    Expertise with industry standard electronic document management system
•    Experience and have good knowledge of e submission. Expertise with Submission Publishing and Document publishing. Also experience of Project and People management.

Preferred Qualifications 
•    Experience in Pharmacy Regulatory Affairs

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: Senior Manager

Job ID: LIF007035

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Mar 11, 2022

Master Skills List: Operations

Job Category: Full Time