Regulatory Product Lead/ Product Owner Job in Vitrana Inc.

Description:

The Product Lead / Associate Product Owner (APO) is directly accountable for the definition and delivery of a part of a platform/suite or module from a customer and regulatory market requirement point of view regarding content, prioritization, quality, and customer excitement for a given cost and time frame. The APO shall be responsible for a part of the platform/suite or module through the product life cycle from the definition to the phase-out.

The APO shall provide to the associated development teams with the priorities and expertise regarding the product and responsible for definition and delivery of a part of a product from a customer and market requirement point of view, working with one or several development teams.

Internal Interactions: Product Line Manager, Product Manager, Project Manager, Quality Manager, Development Team (e.g. Scrum Master, System Analyst, Architect, Developers, Testers), other stakeholders (e.g. Business Units), SCM (Enabling) & Customer Service teams, Technical Writers, etc.

External Interactions: Customers PV Head, PV Operations Managers, Subject Matter Experts, Business Users etc.

Responsibilities:

• Elicit and collect stakeholder requests, while you define and prioritize Requirements
• Analyse Requirements (e.g. initiate and manage concepts for complex regulatory and market requirements)
• Derive, prioritize and communicate Software Requirements
• Create Software Requirement Specifications (i.e. problem part)
• Ensures user stories are captured in detail for development to start work.
• Coach/ support development team s questions and resolve conflict regarding features and requirements
• Analyse and decide complaints and charms
• Achieve commitments with and motivate development teams, assist development teams in attaining maximum effective sustainable pace for development
• Define product vision, roadmap, and growth opportunities and provide backlog management, iteration planning, and elaboration of the user stories.
• Ensure quality by evaluating results of iterations and either approve/ accept or reject results based on acceptance criteria
• Plan and prioritize product backlog and development for the product. Lead the planning product release plans and set the expectation for delivery of new functionalities.
• Support effort estimations of development teams
• Analyse change request entries and prioritize with other product backlog items
• Coordinate cross-feature-area development with peers to facilitate prioritized product development
• Deliver input for project management, support roll-out of the system, presentation, workshops, training for sales and customer demos.
• Hands on technical documentations such as Requirement Specification Document, Business Requirement Document, SOW and so on.
• Provide an active role in mitigating impediments impacting successful team completion of Release/Sprint Goals.
• Keep updated with Agile/Scrum best practices and new trends.
• Ability to participate in client demos, probe questions, work towards building pipeline for future release.
• Research and analyse the market, the customers, and the roadmap for the product.

Requirements:

• BS or MS degree in a relevant discipline with at least 7-10 years of professional work experience in Pharma (preferably in a Regulatory Operations environment)
• Knowledge of the worldwide Health Authority submission formats as well as the overall drug development process and related document requirements is desirable.
• Knowledge and experience with eCTD, IDMP, Publishing Standards and applicable related tools is desirable. Proficiency with RA relevant computer programs and systems with demonstrated ability to learn and train others on new systems quickly
• Strong analytical and problem solving skills. Demonstrates a Quality, Compliance and Innovative mindset.
• Product know-how and customer understanding: sound knowledge of Clinical and Healthcare IT, especially in adverse event management, healthcare industry standards like DICOM and IHE.
• Good understanding of software systems categorized as medical device, drug and vaccine with intermediate knowledge of veterinary-vigilance, cosmetic vigilance and evolving vigilance sciences.
• Exposure to agile methodology, thorough experience in requirements engineering, usability engineering and feature definition activities.
• Product Lifecycle Management & Software development cycle experience.
• Possessing success skills Self driven and takes Initiatives, Decision making skills, Result orientation, Self-motivated and provides motivation and inspiration to the team, Strong Analytical and Problem-Solving Skills. Strong team player and networking skills. Strong written and oral communication skills. Strong interpersonal skills and mainly, a strong customer focus.
• Strong project management and time management skills to manage multiple, complex projects simultaneously.