Regulatory Data

3 days ago

Hyderabad Telangana, India Amgen Full time

**India - Hyderabad**

**JOB ID**:
R-206528

**LOCATION**:

- India - Hyderabad

**WORK LOCATION TYPE**:
On Site

**DATE POSTED**:
Feb. 17, 2025

**CATEGORY**:
Regulatory

Roles & Responsibilities:

- Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements.
- Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices.
- Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives.
- Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates.

Required Knowledge and Skills:

- Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.
- 5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies.
- Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
- Ability to operate effectively in a matrix environment; team player yet able to work independently with mínimal direction.
- Familiarity with GxP requirements and systems validation.
- Life Sciences, Biotech or pharmaceutical industry experience.

Preferred Knowledge and Skills:

- Advanced knowledge of Veeva Vault
- Familiarity with global regulatory processes and standards.
- Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.

Basic Education and Experience:

- Bachelor’s degree and 2 years of directly related experience
- Associate’s degree and 6 years of directly related experience
- High school diploma / GED and 8 years of directly related experience

Preferred Education and Experience:

- Practical experience with regulatory data standards, such as IDMP
- 5+ years’ experience in data management, machine learning, or related fields

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