Analyst I

4 weeks ago


Indianapolis, United States CareerBuilder Full time

Analyst I - Business Process Transactions page is loaded

Analyst I - Business Process Transactions

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locations

IND - AP - HYDERABAD

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

51509507

Job Description:
Experience with various document types (CSR, CMC, Nonclinical, CRF) and applications (IND, NDA, ANDA)
Some global application experience (US, EU, etc.)
Expert in publishing, submission tasks.
Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and Pharmaceutical Industry.
Performs document publishing tasks for authorization of applications, notices and electronic submission forms required by Food and Drug Administration and International Standards Organization regulations.
Experience working on health authority procedures / guidance regarding electronic submissions
Applies knowledge of company and client regulatory publishing process, standard operating procedures, updates to regulatory authority guidelines, and software updates to ensure submission currency and compliance.
Communicates and coordinates effectively with project team members. Ensures timely resolution of publishing issues.
Provides quality and timely deliverables to meet the clients expectation.
May participate in client meetings and lessons learned sessions to address publishing related matters.
Recruitment fraud is a scheme in which fictitious job opportunities are offered to job seekers typically through online services, such as false websites, or through unsolicited emails claiming to be from the company. These emails may request recipients to provide personal information or to make payments as part of their illegitimate recruiting process. DXC does not make offers of employment via social media networks and DXC never asks for any money or payments from applicants at any point in the recruitment process, nor ask a job seeker to purchase IT or other equipment on our behalf. More information on employment scams is available

here

.

About Us

DXC Technology (NYSE: DXC) helps global companies run their mission critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability across public, private and hybrid clouds. The world's largest companies and public sector organizations trust DXC to deploy services across the Enterprise Technology Stack to drive new levels of performance, competitiveness, and customer experience. Learn more about how we deliver excellence for our customers and colleagues at DXC.com .

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