Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will do
Let’s do this. Let’s change the world. In this vital role you will responsible for leading and charting the course for the Regulatory Health Agency Submissions and Clinical Trail details publishing technology product (or services) team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a highly talented team that is built for delivering high-end and innovative technologies.
The ideal candidate will have a proven track record of leadership in technology-driven environments for the Regulaotry Structured Submission area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in regulatory submission and clinical trail publishing, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational pivotal initiatives, foster 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 about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged
Lead and manage large, diverse teams within a matrixed organization.
Collaborate with geographically dispersed teams, including those in the US and other international locations.
Oversee the software development lifecycle
Develop and implement strategic plans for technology and workforce.
Follow global standards and practices.
Foster a culture of collaboration, innovation, and continuous improvement.
Attract and recruit top talent as part of an extensive Technology organization to be hired within India.
Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership.
Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization
Understand the decision-making process, workflows, and business and information needs of business partners and collaborators
Contribute and define business outcomes + requirements, technology solutions, and services
Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through 'test & learn' activities
Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and facilitating communication when service commitments are not met
Ensure communication of key performance metrics and analysis of unmet needs
Participate in collaborator and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery
Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services
Facilitate best practice sharing, ensuring ongoing alignment with the Technology & Digital strategy
Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance
Ensure alignment of Technology service plans across organization
Provide education to new partners with regards to IT service offerings
Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
Doctorate Degree and 2 years of experience in Business, Engineering, IT or related field OR
Master’s degree with 8 - 10 years of experience in Business, Engineering, IT or related field OR
Bachelor’s degree with 10 - 14 years of experience in Business, Engineering, IT or related field OR
Diploma with 14 - 18 years of experience in Business, Engineering, IT or related field
Have excellent knowledge of Veeva and the regulatory health agency submission publishing system like Lorenz’s docuBridge application
Have an excellent knowledge of ClinicalTrials.gov and EudraCT
Have good knowledge of Regulatory Veeva Vault
Have strong business acumen. Can demonstrate a deep understanding of pharma industry regulations, therapy, and product
Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent.
Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
Experience in applying technology best practice methodologies: Scaled Agile (SAFe), ITIL, etc.
Preferred Qualifications:
Strong knowledge of eCTD specification and highy regulated (GxP) systems
Experience in a leadership role within a pharmaceutical or technology organization
Extensive experience in the software development lifecycle of GxP Systems.
Experience using and adoption of Scaled Agile Framework (SAFe)
Strong analytic/critical-thinking and decision-making abilities.
Ability to work effectively in a fast-paced, dynamic environment.
Established business partnerships and IS governance practices involving senior business collaborators
Broad working knowledge of key IS domains and layers
Professional Certifications
ITIL (preferred)
Scaled Agile Framework (SAFe) for Teams
Soft Skills:
Excellent leadership and team management skills.
Strong transformation and change management experience.
Exceptional collaboration and communication skills.
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.
Excellent analytical and troubleshooting skills
Strong verbal and written communication skills
Ability to work effectively with global, virtual teams
Work Hours:
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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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.