Project Manager – End to End Regulatory Content Automation

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content. 

ABOUT THE ROLE

Role Description:

The Project Manager is responsible for overseeing a portfolio of projects and/or programs to ensure that they align with the organization's strategic objectives and deliver maximum value and outcomes. This individual works closely across teams to lead and deliver program and project management services through all phases of the Project Management Lifecycle (PMLC), which include – initiation, planning, development, execution, control, and rollout. This individual is responsible for successful delivery, cost management, resource management, and risk management to drive business outcomes that provide exceptional value to users. This role involves leading and coordinating the efforts of team members and third-party contractors or consultants to deliver projects according to plan, developing and implementing change management strategies and plans that maximize user adoption and minimizes resistance.

Roles & Responsibilities:

• Define project / program scope, goals, and deliverables that support business goals and objectives in collaboration with senior management and stakeholders
• Lead the project team in executing the project plan, monitoring progress, and making adjustments as needed
• Deliver successfully against project schedule, scope, and financial commitments
• Maintain budgetary responsibility of the project(s)
• Implementation of cost saving measures based on planning and efficiency
• Identify potential risks and develop mitigation strategies
• Ensure that project deliverables meet quality standards, business requirements, and intended outcomes
• Maintain comprehensive project documentation, including plans, reports, and post-project evaluations
• Coordinate resources across projects, managing dependencies and resolving conflicts
• Track ongoing program performance throughout using appropriate tools and techniques, ensuring that the program delivers the expected benefits

Basic Qualifications and Experience:

• Doctorate Degree OR
• Master’s degree with 4 - 6 years of experience in Computer Science, IT or related field  OR
• Bachelor’s degree with 6 - 8 years of experience in Computer Science, IT or related field  OR
• Diploma with 10 - 12 years of experience in Computer Science, IT or related field

Functional Skills:

Must-Have Skills:

• Proven track record of delivering high impact projects that meet and exceed the project objectives and success measures
• Ability to proactively chart the course for project delivery and effectively work through project risks and challenges to successfully deliver business outcomes
• Extensive knowledge of program and project management methodologies
• Experience and strong knowledge of portfolio management methodologies and frameworks
• Cost & Budget management with detailed financial tracking experience of projects and/or programs with ongoing status reporting to stakeholders
• Strong knowledge of change management principles and methodologies
• Experience successfully delivering technology enabling projects that produce tangible outcomes and business value
• Experience with Agile delivery – Product team participation and experience
• Experience with project analysis tools such as Plangrid, Jira, Bluebeam, eBuilder, MS Project, etc.

Good-to-Have Skills:

• Proficiency with program management software and tools
• Proven ability to execute and deliver on a complex portfolio of projects and programs
• Experience with delivering successful organizational change initiatives and transformations
• Experience delivering GxP projects in the life sciences space and successfully taking through the required qualification processes (e.g., IQ, OQ, PQ, etc.)

Professional Certifications:

• Project Management Professional (PMP) or equivalent certification (preferred)
• Certified Change Management Professional (CCMP) or equivalent (preferred)

Soft Skills:

• Excellent analytical and troubleshooting skills
• Excellent leadership and strategic thinking abilities
• 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
• Ability to deal with ambiguity and think on their feet
• Ability to influence and drive to an intended outcome
• Ability to hold team members accountable to commitments

Shift Information:

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 an accommodation.