Senior Manager, Information Systems

What you will do

Lets do this. Lets 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
• Masters degree with 8 - 10 years of experience in Business, Engineering, IT or related field OR
• Bachelors 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 Lorenzs 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.