Software Product Owner

Job Description

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Job Description

OBJECTIVES/PURPOSE

The Product Owner SACA+ is responsible for owning the vision and product strategy for an internally facing compliance platform and administering Takeda’s digital asset compliance process framework. This role plays a crucial part in enabling the design, development, and deployment of externally facing digital solutions to patients and healthcare professionals while ensuring the highest standards of quality and compliance.

The objectives of this role include:

• Define and own the product vision and strategy for the compliance platform.

• Align the platform’s product roadmap with business needs and compliance requirements.

• Ensure the platform meets the needs of internal stakeholders, including business owners and compliance reviewers.

• Oversee the end-to-end management of the compliance platform, ensuring robust and scalable solutions.

• Collaborate with cross-functional teams, including software developers, testers, project managers, and business teams, to deliver on the product vision.

• Prioritize and manage platform requirements to ensure alignment with stakeholder needs and compliance standards.

• Enabling, perform and manage Customer Experience Product Ownership for USBU, and overseeing delivery across all delivery partners.

• Guide the compliance assessment process for digital health products and assets, ensuring adherence to global SOPs.

• Work with digital asset owners to ensure comprehensive stakeholder review, including privacy, legal, E&C, patient safety reporting, quality, and regulatory review.

• Provide expertise in deciphering regulatory classifications for digital assets, including SOX, non-GxP, GxP, or SaMD.

• Lead the communication strategy for platform updates and SOP rollouts, ensuring clear and effective dissemination of information.

• Foster strong relationships with internal and external partners, ensuring alignment on compliance processes and platform updates.

• Ensure that platform users are well-informed and supported in their compliance efforts.

• Demonstrate solid delivery of commitments within agreed timelines, requiring excellent project management, organizational, and communication skills.

• Track project scope, manage risks, and communicate progress to stakeholders.

• Ensure the delivery of high-quality, compliant digital solutions that meet business and regulatory requirements.

ACCOUNTABILITIES

• Manage the end-to-end product vision for the compliance platform, including a broad set of technologies and services.

• Prioritize requirements from a diverse set of stakeholders, ensuring alignment with business owners and compliance reviewers.

• Lead cross-functional team alignment and delivery, collaborating with software developers, testers, project managers, business, and compliance teams.

• Develop and execute the communication strategy for platform updates and SOP rollouts.

• Ensure timely and quality delivery of platform features and updates, demonstrating strong project management skills.

• Partner with the Digital Health Solutions Marketplace Product Manager to ensure a cohesive user experience for digital asset landscaping.

• Ensure digital health products and assets registered on the platform undergo necessary stakeholder reviews, including privacy, legal, E&C, patient safety, quality, and regulatory assessments.

• Guide teams in determining the regulatory classification of digital assets (e.g., SOX, non-GxP, GxP, SaMD).

• Collaborate with digital asset owners to ensure compliance with global SOPs and facilitate the compliance assessment process.

• Build strong relationships with internal and external partners, fostering trust and collaboration.

• Serve as a trusted advisor to business and compliance teams, providing expert guidance on platform utilization and compliance processes.

• Act as a key point of contact for stakeholders utilizing the compliance platform, ensuring their needs are met and issues are resolved promptly.

OTHER DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

• Extensive knowledge of compliance platforms, digital asset management, and regulatory requirements in the healthcare industry.
• Familiarity with software development processes, including Agile methodologies and the software development lifecycle.
• Experience in integrating various technologies and services to create comprehensive and scalable solutions.
• Proven ability to manage product vision, strategy, and roadmaps, ensuring alignment with business and compliance needs.
• Expertise in guiding the compliance assessment process, including privacy, legal, E&C, patient safety, quality, and regulatory reviews.

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Ability to define and articulate a clear vision for the compliance platform, inspiring and guiding cross-functional teams towards achieving it.
• Skilled in influencing stakeholders across various departments and levels of the organization to drive platform adoption and alignment.
• Strong ability to lead cross-functional teams, fostering a collaborative environment that encourages innovation and continuous improvement.
• Excellent written and oral communication skills, capable of effectively conveying complex technical information to non-technical stakeholders.

Decision-making and Autonomy

• Ability to make autonomous decisions that serve the business's and Takeda's best interests.
• Proficient in connecting, orchestrating, and influencing different stakeholders to drive affordable, usable solutions and business value.
• Strong problem-solving skills, with the ability to identify issues and provide effective solutions promptly.

Interaction

• Ability to build and maintain strong working relationships with business leaders, DDT teams, and other stakeholders.
• Skilled in fostering alignment across all levels of the organization, ensuring clear and effective communication.
• Act as a trusted advisor to the business, providing expert guidance on compliance platform utilization and development.

Innovation

• Innovate and shape technology development within the compliance platform, applying industry trends and best practices.
• Function as a thought leader and evangelist for innovative technology, bringing new perspectives on startups and innovative products.
• Foster a culture of continuous improvement, encouraging team members to identify and implement enhancements to the platform.

Complexity

• Ability to cooperate with and inspire various stakeholders across business and technical domains and global regions.
• Capable of setting up and continuously shaping the development of innovative technology within the compliance platform ecosystem, involving third-party vendors and Takeda stakeholders.
• Navigate complex regulatory environments, ensuring all platform developments comply with relevant standards and requirements.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Essential

• Degree in Computer Science/Business Informatics or other relevant graduate degree required;
• Demonstrated project results in commercial and/or digital technical delivery.
• Experience in digital or software product development and product management.
• Experience in developing and maintaining cross-functional relationships.
• Experience working in a life sciences environment and/or familiarity with Takeda strongly preferred.
• Understanding of regulatory requirements and compliance processes, particularly in the healthcare industry.
• Experience guiding compliance assessments and ensuring adherence to global SOPs

Desired

• Master’s Degree
• Familiarity with regulated systems – general level of understanding of computer systems validation.
• Experience as a Product Owner / Manager with software products;

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