Lead Associate – Regulatory Affairs–LIF008714
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 Management Trainee, Publisher
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 of eCTD submissions for 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 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.
- Co-ordinate with client/stakeholders
- Project Management skills
Minimum qualifications:
- B. Pham/M.Pharm/Science Graduate
- Experience and have good knowledge of eCTD submissions and Structure & Expertise with Publishing Tools like Liquent Insight Publisher, Lorenz Docubridge, Extedo eCTDManager etc.
- 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
- Preferred Qualifications / Skills: Pharmacy
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 http://www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
CLICK HERE TO APPLY ONLINE
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