Associate Director, GDS Product Owner


: $162,355.00 - $206,040.00 /year *

Employment Type

: Full-Time


: Advertising/Marketing/Public Relations


GDS Technology Product Owner is a key member of the Global Development (GD) Systems organization, who is responsible for managing Global Development Systems core technology platforms 'Plan, Build and Run'. The position requires subject matter expertise in 'Pharmaceutical Development' [Clinical Trial Operations, Regulatory Affairs, Medical Affairs, Biometrics/Data Management, Pharmacovigilance Safety Case Processing, Safety Reporting, Risk Management and Signal Detection] processes and technologies. This individual interacts with Platform Technology Vendors, Corporate IT on the day-to-day support of standard technology platforms, while also focusing on improving operational support including direct oversight of Managed Service Providers & platform vendors.

This role is responsible for architecture, integration, and implementation of reliable cross funtional services for GDS technology platforms (e.g., Veeva Vault, SharePoint, SAS, etc), from the ground up, to deliver highly scalable services. Additional responsibilities include: day to day operational support and coordination with internal operations and support groups and ensuring security, reliability, and scalability of the GDS platform technologies. The role requires excellent business analysis and management skills. This individual partners with Global Development personnel in understanding business challenges and proposes solutions and provides leadership on support and projects. He/she must have excellent interpersonal, presentation and writing skills.

Job Duties:
  • Responsible for the entire lifecycle of a feature and/or capability set in a product.
  • Plans and prioritizes product feature backlog and development for the product.
  • Builds relationships across engineering, UX, marketing and other stakeholders. Serves as a liaison between developers and other team members.
  • Assesses value, develops business cases, and prioritizes stories, epics and themes to ensure work is aligned with product strategy.
  • Provides backlog management, iteration planning, and elaboration of the user stories.
  • Works closely with Product Management leadership to create and maintain a product backlog according to business value.
  • Leads the planning product release plans and sets expectation for delivery of new functionalities.
  • Researches and analyzes the market, the users, and the roadmap for the product.
  • Accountable for ensuring day-to-day GDS Run operational support meet business expectations and compliance requirements.
  • Accountable for development of GDS platform level technical and development best practice policies and procedures.
  • Accountable for platform governance when implement new or upgrade to existing solutions.
  • Provides leadership and subject matter expertise on projects to effectively manage business user expectations, timelines, and budget.
  • Maintains the validated state of GxP Platforms.
  • Oversee outsourced Managed Service technical support vendors involved in maintaining applications leveraging the platform.
  • Works collaboratively with Platform Vendors, Corporate IT in the management of enterprise systems leveraging the platforms in scope of this role. Development and adherence to standards and governance, enterprise architecture and common infrastructure
  • Direct experience in technologies for Veeva Vault, Integration Platforms, Service Management, GxP Validation, Change Control.
  • Understands Pharmaceutical Development business domain and/or technology very well and can analyze business challenges and present technology solutions.
  • Partners with vendors in keeping abreast of technology trends and applicability to business needs.
  • Accountable for career development for GDS staff within the functional areas
  • Functions as point of contact for Global Development Functional Organization Management when it comes to the Technology Platforms in scope of this role.
  • Provide day to day operational support and performs platform level systems administration tasks by leading platform level operating committee(s).
  • Design and develop integration strategy and continuous delivery systems and methodologies for GDS technology platforms
  • Apply industry standards and best practices to ensure consistent operations across function
  • Drive automation of operations and integration management of GDS
  • Accountable for architecture, integration, and implementation of reliable and scalable infrastructure services for GDS technology platforms (e.g., Veeva Vault, SharePoint, SAS, etc), from the ground up, to
  • Additional responsibilities include day to day operational support and coordination with internal operations and support groups and ensuring security, reliability, and scalability of the GDS platform technologies.
  • Accountable in the develop of Business Practice Tool (BPT)
  • Minimum 10 years' experience in managing IT contractors and staff
  • Experience in more than one area -
    • Managing complex high-impact IT projects from start to finish
    • Supporting and Administrating Pharmaceutical Development Systems
    • Business Analysis, Data Modeling, Information Architecture
  • Proven expertise delivering continuous user value through breakout and UX design via Agile delivery frameworks.
  • Experience integrating user research into product designs and design practices.
  • Proven ability to work across teams and synthesize feedback and input from product management, engineering, and marketing.
  • Strong experience building and executing usability assessments for prototypes.
  • Good problem solving, technical writing and verbal communication skills
  • Ability to effectively manage multiple priorities with a sense of urgency
  • Attention to detail and accuracy of work
  • Strong knowledge of SDLC methodologies and CFR Part 11 compliance
  • Expert in the use of Microsoft Office Suite ( Word, Excel, Power Point, Project, Visio)
  • Good understanding of Pharmaceutical Development business processes
  • Strong knowledge of business analysis, system design and producing quality documentation
  • Strong knowledge of technologies Veeva Vault, SharePoint, Integration Tools 'Dell Boomi, etc..
  • BS/BA Degree with 10+ years relevant experience or MS degree and 8+ years relevant experience.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
- * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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