The Variation Lead will be accountable for driving the cross-functional execution of a portfolio of variation projects for Amgen's commercial products. The position will be a great opportunity to help design, establish and build a high-performing team and capability that will support the end-to-end variation management process. Holistically, this group will be focused on robust project, portfolio, and process management for variations to capture and accelerate the value of change to our commercial products.
The scope of the variation management process directionally includes: business case approval for a change, variation portfolio prioritization, change control, supply and submission planning, content authoring, publishing, submission, and approval from global regulatory agencies.
Drive end-to-end execution of a Product Delivery Team's (PDT) variation portfolio (or cross-product in some cases) - navigating/supporting business case development through global regulatory approvals.
Partner with functional project managers of technical implementation activities.
Liaise with PDT members to develop the variation business case & execution strategy and portfolio planners to optimize timing and scope.
Communicate priorities to product, functional, and regional stakeholders, identify and resolve issues, escalate to appropriate governance.
Adhere to processes and best practices set by Business Process Owner, drive continuous improvement of processes.
Guide variations through governance process.
Standardize and integrate project management tools; establish single source of truth for variation status.
Travel up to 10%.
Doctorate degree OR
Master's degree and 3 years of Operations, Regulatory, or Project Management experience OR
Bachelor's degree and 5 years of Operations, Regulatory, or Project Management experience OR
Associates degree and 10 years of Operations, Regulatory, or Project Management experience OR
High school diploma / GED and 12 years of Operations, Regulatory, or Project Management experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
6+ years biotech or pharmaceutical industry experience
Able to facilitate and influence senior clients and partners
Able to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to negotiate a strategic position after taking feedback from multiple sources
Strong project management, problem-solving, and analytical skills; experience with project management tools
Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
Ability to operate in a matrixed or team environment with site, functional, and executive leadership
Comfortable in "start-up" environment of a new Amgen group
Experience driving decision making using DAI principles
Some experience with the "variation management" processes
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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