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Analyst- Business Process Transactions

Analyst- Business Process Transactions

ScaleneWorksBengaluru, Karnataka, India
30+ days ago
Job type
  • Quick Apply
Job description

Please refer to the below details.

Successfully meet / complete training milestones relevant to the position held.

Familiarity with FDA, GCPs, ICH guidelines, Life Sciences & Pharmaceutical industry

Familiarity of health authority procedures / guidance regarding electronic submissions

Perform submission publishing, assembly, and distribution activities within the specified training period

Notifying relevant stakeholders that the file is ready for approval

Multi-skilled on all allocated submissions within the team

Adapting and willing to multi-skill and assisting in other submission / task within the team

A high level of independent judgment / action in problem solving

Keeping Team Leader informed of non-routine issues, making recommendations to resolve these issues

Self-Development and Take Responsibilities for the same

Active involvement in projects and quality / change initiatives

By continually upgrading domain knowledge

Following company rules and standard operating procedures

Adhering to all Security Policies and Procedures

Promoting a positive and professional image of the team always

Need to abide to the existing Information Security Policies and Procedures

Bachelor s degree in life sciences specialty (pharmaceutical / biotech) 1-2 years of Regulatory Publishing experience

Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry

Experience with various document types (CSR, CMC, Nonclinical, CRF) and applications (IND, NDA, ANDA)

Familiarity of health authority procedures / guidance regarding electronic submissions.

Some global application experience (US, EU, etc.)

Minimal supervision required for common publishing tasks.

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Analyst • Bengaluru, Karnataka, India

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