IS Organizational Effectiveness Manager – Regulatory Structured Submission

Career Category

Information Systems

Job Description

What you will do

Let’s do this. Let’s change the world. In this vital role you will facilitate Scrum events and processes for the Regulatory Structured Submissions Team. Your responsibilities include enhancing team communication and collaboration, ensuring alignment with program goals, managing risks and dependencies, and driving continuous improvement. The Scrum Master adapts and refines SAFe principles to suit organizational needs, standardizing and documenting practices.

The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile framework practitioner, coupled with leadership and transformation experience

Roles & Responsibilities:

• 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 partners, 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 partners 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 partners.
• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree / Master's degree / Bachelor's degree and 8 to 13 years Computer Science, IT or related field

Preferred Qualifications:

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.
• Proven experience as a Scrum Master with a solid background in the end-to-end software development lifecycle.
• Expertise in Scaled Agile framework practices and principles.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Experience with Agile project management tools such as Jira and ServiceNow.
• Expertise in defining and implementing validation strategies aligned with regulatory requirements.
• Ability to manage and resolve impediments, ensuring timely delivery of project achievements.
• Strong problem-solving skills and the ability to foster a culture of continuous improvement.
• 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)
• CSM/CSP/SAFe SM/PMI ACP

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.

Equal opportunity statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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