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 leveragesstate-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
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 leveragesstate-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content.
Role Description:
Let’s do this. Let’s change the world. In this vital role as Senior Manager Information Systems, you will lead a dynamic team of technical product owners, business analysts, test/validation engineers, project managers and scrum masters responsible for the ongoing design, development, management, and optimization of Amgen’s digital productsenabling the regulatory submission content automation initiative. You will also be the reporting manager for this team and will be responsible for the coaching and development of these resources.
The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires deep expertise in handling the end-to-end development and delivery of customer-facing digital product capabilities and platforms including generative AI, structured content management.
They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure.
Roles & Responsibilities:
Maintain strategic relationships and strong communication with the leadership team to ensure all collaborators feel informed and engaged
Oversee the software development lifecycle, ensuring standard methodologies in development, testing, and deployment across the product teams
Lead and handle large, teams with varied strengths within a matrixed organization, collaborating with geographically dispersed teams, including those in the US and international locations
Develop and implement strategic plans for technology and workforce growth, including recruiting top talent and building a robust team in India
Developing talent, motivating the team, delegating effectively, championing diversity within the team, and acting as a role model of servant leadership
Ensuring global ways of working are embedded in the local organization
Develop a culture of collaboration, innovation, and continuous improvement, driving talent development, motivation, and effective delegation
Fostering standard methodology sharing and alignment with business goals
Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet
Participate in team member and leadership meetings, working with other parts of the organization and functional groups to ensure successful delivery and alignment with strategy, compliance, and regulatory requirements
Remain accountable for ensuring overall organizational compliance with quality and GxPin technology services
Monitor emerging technologies and trends to find opportunities for platform growth and expansion
Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services
Basic Qualifications:
Doctorate Degree and 2 years of experience in Engineering, IT or related field OR
Master’s degree with 8 - 10 years of experience in Engineering, IT or related field OR
Bachelor’s degree with 10 - 14 years of experience in Engineering, IT or related field OR
Diploma with 14 - 18 years of experience in Engineering, IT or related field
Functional Skills:
Must-Have Skills:
Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuring the ability to oversee and guide ateam totranslate business needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate delivery and management of the digital products.
Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technologyprofessionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements.
Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology.
Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects.
Degree in Computer Science, Information Systems, Engineering, or Life Sciences.
Good-to-Have Skills:
At least 5 – 8 years of domain knowledge in health and/or life sciences combined with Information Technology
Understanding, and preferably applied experience and knowledge, in data management and CTD document drafting
Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation.
Experience driving a collaborative culture that values technical depth, accountability, and customer service.
Strong problem-solving and analytical skills.
Demonstrated ability to work effectively in a fast-paced, dynamic environment.
Understanding of ITIL processes and implementation.
Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products.
Soft Skills:
Excellent analytical and troubleshooting 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.
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.