Senior Manager, Information Systems

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.