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Amgen
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Sr Associate IS Organizational Effectiveness - Veeva Vault eTMF

Sr Associate IS Organizational Effectiveness - Veeva Vault eTMF

Amgen

5 - 9 years

8 Lacs

Hyderabad

Posted:1 week ago| Platform:

Apply

Skills Required

Business Analyst Business analysis Analytical Agile Oncology Public speaking Scrum Continuous improvement Operations SDLC

Work Mode

Work from Office

Job Type

Full Time

Job Description

Let s do this. Let s change the world. In this vital role you will

Lead and handle product delivery using agile frameworks and techniques.
Align with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team.
Capture the voice of the customer to define business processes and product needs
Collaborate with business collaborators, Architects and Engineering teams to prioritize release scopes and refine the Product backlog
Lead and facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team
Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog
Ensure Acceptance Criteria and Definition of Done are well-defined
Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops.
Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators
Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements
Identify and manage risks associated with the systems, requirement validation, and user acceptance
Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users
Collaborate with geographically dispersed teams, including those in the US and other international locations.
Develop a culture of collaboration, innovation, and continuous improvement

Basic Qualifications and Experience:

Masters degree / Bachelors degree and 5 to 9 years

Functional Skills:

Must-Have Skills:

6-8 years of experience working in global pharmaceutical Industry
Solid understanding of GxP regulations, specifically 21 CFR Part 11.
Expertise in defining and implementing validation strategies aligned with regulatory requirements.
Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)).
Good communication skills and the ability to collaborate with senior leadership with confidence and clarity.
Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager Vault etc.

Good-to-Have Skills:

Proficiency in automation tools and validation software.
Experience of DevOps, Continuous Integration and Continuous Delivery methodologies.
Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile etc.).

Professional Certifications:

SAFe for Teams (Must-Have)
Veeva Vault Platform Administrator (preferred)

Soft Skills:

Able to work under minimal supervision.
Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work.
Excellent analytical and gap/fit assessment skills.
Strong verbal and written communication skills.
Ability to work effectively with global, virtual teams.
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Team-oriented, with a focus on achieving team goals.
Strong presentation and public speaking skills.

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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Sr Associate IS Organizational Effectiveness - Veeva Vault eTMF