Senior IT Director, Business Technology Leader (BTL) and Product Line Owner (PLO), Global Regulatory - United States, Belgium
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- Our company is currently recruiting for a Senior Manager, CLS GDO EHSS & Support Services.
- Our company provides account management and customer support services to key health care customers, including hospital systems and group purchasing organizations, leading health plans, pharmacy benefit managers, and government health care institutions.
- The company also provides contract management, logistics and supply chain functions for the major franchises.
- Our company is a global Supply Chain organization that supports operating units across all of our Family of Companies.
- Our company strives to deliver an exceptional customer experience through leading critical customer facing-functions such as distribution and transportation.
- In addition, CLS oversees critical business enablers, including how we gather and manage supply chain master data, safe and secure supply chain practices, product identification standards, and market/channel access capabilities. CLS supports all three sectors. : Medical Device & Diagnostics, Pharmaceutical, and Consumer Products.
- This team is represented in multiple countries, and continues to grow globally in both visibility and responsibility.
- The CLS team reports to our company's Supply Chain and partners closely with groups throughout the supply chain organization.
- The IT Senior Director, BTL/PLO Global Regulatory Affairs (GRA) is a strong leader who can combine consulting, modern Information Technology (IT) expertise, and pharmaceutical and biotechnology regulatory knowledge to transform the way IT is applied in Global Regulatory.
- This role is accountable for information and technology initiatives that maintain compliant operations as well as modernize workflow and regulatory operations capabilities.
- As a strategic partner to the GRA leaders, the IT Senior Director BTL/PLO will influence future information and technology evolution.
- In addition to ensuring continuous improvement advances, s/he will build internal and external partnerships for technology evolution, accounting for potential regulatory changes arising with digital health, social platforms, convergence of therapy and device, data sciences, and automated practices in the healthcare ecosystem.
- The Senior IT Director BTL/PLO GRA reports to the company Vice President and CIO R&D and is a core member of the senior leadership team of R&D IT, as well as is an extended team member of Pharma Global Regulatory Affairs senior leadership team.
- This role will assume responsibility and direct accountability for the delivery of various regulatory programs within company including the Regulatory Information Management (RIM) program which consists of Product & Life-cycle Registration, the Submission Planning, Tracking, and Processing utilities, as well as the future state Content Management System.
- The incumbent will be expected to possess a clear understanding of integrated, platform technology and work closely with external service providers to ensure delivery of solutions.
- The Senior IT Director, BTL/PLO Global Regulatory Affairs manages directly a small team of Business Technology Leaders (BTLs) that provide IT strategy, tactics, business consultancy, solution architecture, and program/project management.
- S/he additionally manages a Product Line Organization (PLO) of 8-10 professionals responsible for provision of solutions at scale, leveraging matrixed IT organizations for solution development, advanced analytics and other information technology-related services.
- This role is the accountable strategic R&D partner who manages the relationship through ongoing consultation with the business, and s/he also owns the full outcome of the information and technology services provided to these business partners.
Additional specific responsibilities include:
- Develops an IT strategy and road-map for Global Regulatory Affairs aligned to the company business objectives and the IT strategy
- Collaborates closely with architecture to build road-maps, ensure end to end process and data flow and evaluate potential technology partners
- Advises and influences senior management on the marketplace evolution and potential application of information and technology, aligned to the overall R&D IT strategy
- Builds superior skills within a strong overall team, owning performance management, talent development and succession for his/her area of responsibility and contributes to the same for the broader R&D IT group
- Represents our company in relevant industry groups and provides a key interface for external IT/informatics partners, collaborators and thought leaders
- Ensures compliance, audit readiness and operational stability of the Global Regulatory Affairs application landscape
- Addresses complex problems with broad implications for IT architecture, balancing the often competing needs of standardization and innovation
- Makes decisions regarding resource alignment/dedication and prioritization (people resources, dollars/funding, project critical) and communicates rationale back to the business
- Applies compliance requirements within scope of responsibility, provides documentation as necessary, and participates in compliance activities as required
- In close partnership with senior business stakeholders, manages governance processes and resources, and will consistently influence, match and prioritize complex demands on multiple informatics and IT services to maximize value to the business.
- Deep knowledge of the pharmaceutical business and prior leadership in information and technology support in this domain
- Deep knowledge of Regulatory Information Management needs including Product & Life-cycle registration, submissions tracking & management, data standards, labeling, content management and health authority communication tracking
- Deep knowledge of computer systems validation requirements and all necessary compliance requirements for workflow, reporting, and information custody for medicinal products companies
- A driver of improved business operations who utilizes robust project management to ensure timely delivery of projects that achieve expected benefits
- A strategic thinker with good technical knowledge and excellent communication and leadership skills, used to influence decision making with business leader
- A business strategist, pragmatic as needed but capable of innovative thinking relative to new and emerging technologies and analytics, and capable of applying innovative capabilities where appropriate
- An IT pragmatist, who knows when to leverage corporate infrastructure to deliver upon traditional needs as well as unlock opportunities for innovation from technology
- A flexible leader that thrives in a rapidly changing technology and business environment while scaling for excellence and global expansion
- An authentic leader committed to diversity and the practices that create a passionate, energetic and rewarding work environment, with the ability to inspire a diverse, multi-generational workforce and that recognizes and rewards collaboration, performance and inclusion
- Strong understanding of technology trends and the potential impact on the company system portfolio
- Strong understanding of the business and its operating environment (e.g., trends, competitors, compliance landscape, and regulatory environment).
- A minimum of a Bachelor’s degree or equivalent and 8 years of related experience in regulatory or clinical development operations IT applied to a pharmaceutical or contract research organization setting.
- Strong knowledge of the medicinal product R&D and commercial business and prior leadership in information and technology support in this domain, with demonstrated experience driving new system implementation is required.
- Strong knowledge of regulatory reporting processes, computer systems validation requirements, and all necessary compliance requirements for workflow, reporting, and information custody is required.
- Strong communication skills, and strong relationship development and management capabilities in a global setting is required.
- Knowledge of current and new technologies & their applicability to the business is required.
- Strong knowledge of analytics opportunity and principles and practical application, including various data standards is required.
- Experience managing matrixed, consultant, and internal and external technical personnel in a fast-paced, complex, global project environment is required.
- Experience managing global business priorities and projects across multiple business areas is required.
- Strong business process knowledge, and a demonstrated capability to apply technology solutions in addressing complex, global business issues is required.
- Outstanding oral and written communication skills are required.
- The ability to work in cross functional teams and lead and manage individuals with multidisciplinary backgrounds is required.
- A thorough understanding of:
- 1) methodologies for system design, development, and implementation;
- 2) all phases of the Project Implementation life cycle;
- 3) validation and regulatory requirements is required.
- Experience in the use of Agile methodology, process engineering and prototyping tools is preferred.
- Up to 15% travel (domestic & international) is required.