Job Description

The Senior Specialist of Digital Innovation & Systems will be accountable for the oversight of various tools and systems utilized by the Regulatory Planning and Publishing (RPP) Team. This position will understand the enterprise-wide tools utilized by RPP and the implications of the GRACS Digital Strategy including the new tools associated with the strategy and its impact on Regulatory Submission Planning & Publishing as GRACS moves to creating a future state of working with data that are more connected and agile.

The position will work closely with the DIS Associate Directors Regulatory Innovation & Information Management (RIIM) and Information Technology (IT) on various projects. They will assist with ensuring the perspective of RPP is taken into consideration during tool development and/ or modifications. They will work towards ensuring there is an understanding of the cross-tool/ business process connections for all aspects of our digital capabilities as it impacts the RPP Team. This position will serve a key role to ensuring robust change management including communications and training is available to the RPP team as each aspect of the Digital Strategy is rolled out.

Key Responsibilities:

Project Management: Foundational understanding of planning executing and overseeing projects to achieve team-oriented goals ensuring project requirements are met to the satisfaction of stakeholders and contributing to organizational success.

- Understand the fundamentals of the existing enterprise-wide digital tools available to and/or utilized by the RPP Team and recommend adoption of new digital tools supported by Microsoft AI and others for the RPP Team.

- Understand the GRACS Digital Strategy and its impact on the RPP Team including which existing tools will be modified or retired and which new tools will be introduced.

- Represent Regulatory Planning and Publishing and the Project Management profession in forums outside the department and outside the company.

Problem Solving and Critical Thinking: Capable of analysing and evaluating systems and processes adopting a proactive approach to challenges through effective problem-solving.

- Enhance operational excellence ensure high-quality data and drive innovation through collaborative ideation and the strategic adoption of new/enhanced technologies.

- With guidance from manager contribute to process improvements within various tools to increase efficiency and effectiveness.

- Raise any potential quality or compliance risks associated with the use of the various GRACS tools to the RPP Quality & Compliance Management Director and/or DIS Leadership.

Facilitation: Foundational skills in leading discussions and decision-making processes to enhance collaboration and productivity within cross-functional teams encouraging participation managing conflicts and structuring discussions to meet team objectives.

- Mentor and coach RPP personnel impacted by tool or business process changes on the concepts methods and nuances of the changes.

- May perform testing on various tools/systems and provide subsequent training to RPP.

Communication Skills: Demonstrates the ability to communicate clearly and effectively both verbally and in writing across various organizational levels.

- Raise any potential quality or compliance risks associated with the use of the various GRACS tools to the RPP Quality & Compliance Management Director and/or DIS Leadership.

- Represent Regulatory Planning and Publishing and the Project Management profession in forums outside the department and outside the company

Education Minimum Requirement:

- High School diploma or equivalent plus 10 years of relevant experience

- Associate degree plus 8 years of relevant experience

- Bachelors degree plus 5 years relevant experience

Desired Experience & Skills:

- 5 years pharmaceutical experience with emphasis on business process and supporting technology preferably within a regulatory affairs function.

- Experience with platforms and processes enabling regulatory submission planning document management publishing and submission tracking.

- Skilled at gathering stakeholder inputs and translating them into clear actionable business requirements.

- Working knowledge of solution platforms such as Microsoft Power Platform SharePoint and Generative AI with proficiency in coding languages (e.g. Python) to deliver applications and data-driven reports/metrics.

- Demonstrated ability to assess operations and pinpoint opportunities where technology solutions (e.g. automation analytics integrations) can drive measurable improvements.

- Demonstrated situational leadership and creative problem solving within organizations and teams.

- Strong interpersonal skills and experience in handling diverse cultures with effective communication skills in English and regional to lead by influence and work effectively in matrix organizational structures.

- Strong understanding of Application Lifecycle Management (ALM) and Software Development Lifecycle (SDLC) principles and best practices.

- Expert in project management methodologies (e.g. PMP Sigma Change Management etc.) and associated toolsets (e.g. MS Project for project planning MS Excel for data analysis and reporting).

- The incumbent may manage a team of direct reports and will be committed to investing in the growth success and well-being of this team.

- Drive team performance: Help team set clear priorities aligned to Our Strategic Priorities and check in with them regularly to guide their work.

- Create a feedback culture: Create a safe environment for giving and receiving impactful feedback to drive performance and growth.

- Develop every team member: Partner with every member of team to identify development opportunities in line with their aspiration and the needs of the business.

- May perform other duties as assigned

Required Skills:

Preferred Skills:

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