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15 NDA Jobs in Hyderabad / Secunderabad

Analyst II Business Process Transactions

0-5 years

₹ 4 - 6L/yr (AmbitionBox estimate)

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Hyderabad / Secunderabad

1 vacancy

Analyst II Business Process Transactions

DXC Technology

posted 4hr ago

Job Description

Job Description:

Provides publishing support for regulatory submissions within the life sciences industry. Includes document level and submission level publishing, archive activities, report publishing, general PDF navigation, conversion of paper documents to electronic format, and paper submissions.
Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry
Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and Pharmaceutical Industry.
Familiarity of health authority procedures / guidance regarding electronic submissions
Supports electronic communication and submission processes including general correspondence, reports and amendments. Provides quality and timely deliverables to meet the client s expectations.
Supports end-to-end publishing services which may include lifecycle management. Works independently with minimal supervision on common publishing tasks.
Develops understanding and maintains knowledge of appropriate standard operating procedures (SOPs), regulations, and policies. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Provides regularly scheduled status on project metrics including hours spent, publishing efforts, etc. to the necessary project stakeholders both internally and externally.
Builds knowledge of company and client regulatory publishing process, updates to regulatory authority guidelines, and software updates to ensure currency and compliance.
Experience with various document types (CSR, CMC, Nonclinical, CRF) and applications (IND, NDA, ANDA)
Some global application experience (US, EU, etc. )
Minimal supervision required for common publishing tasks

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 .


Employment Type: Full Time, Permanent

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What people at DXC Technology are saying

3.4
 Rating based on 73 Analyst II reviews

Likes

Everything is good as it is giving permanent work from home. But, it is the only benefit from this company. Also maintains work - life balance great and colleagues and management is quite good.

  • Skill development - Good
  • +3 more
Dislikes

No Appraisals and proper appreciation for the work you have done and no regular hikes.

Read 73 Analyst II reviews

Analyst II salary at DXC Technology

reported by 459 employees
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₹2.5 L/yr - ₹7.5 L/yr
34% less than the average Analyst II Salary in India
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