GlaxoSmithKline Hiring for Clinical Document Automation Product Owner at Collegeville, PA  Full Time

Role : Clinical Document Automation Product Owner

Location : GSK House (Brentford as of now and later Tottenham court ) / Upper Providence , USA / Banglore)

Duration : 24 months

Job Purpose

The Clinical Document Automation Product Owner is accountable for designing and delivering the roadmap that will improve the user experience for the products within their domain and support the strategic priorities. Each Product Owner will work collaboratively with stakeholders to agree on priorities within their domain and build plans to deliver against those priorities.

The Product Owner will have ownership and responsibility for the products within the respective product set. Primary business stakeholders benefiting from these capabilities include Medical Writers, Study Delivery Leads, Data Management, Statisticians and Programmers. Tools aligned to this area would focus on comprehensive suite of clinical document automation capabilities supporting clinical development lifecycle from protocol design to regulatory submissions. This could include digitization of clinical study components to enable automation, interoperability, and reuse across the study lifecycle. These tools helps modernize clinical trials by enabling a digital data flow that allows for the automated creation of study assets and configuration of study systems to support clinical trial execution and automation of documents to support study startup, conduct, close out and regulatory submissions.

The Product Owner is recognized as the go to leader and trusted advisor for their product set – removing blockers, working collaboratively and adaptively to constantly meet the needs of their customers and deliver value to GSK.

Key Responsibilities:

This role will provide YOU with the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Technology Strategy & Enablement: in the role of trusted advisor, strong domain knowledge including business process, industry best practices, in market solutions
• Demand management: Collaborate with business stakeholders to manage and prioritize the product backlog to produce the product set with the highest business value. Accountable for the product backlog and product cost forecast.
• Governance: Establish business value, manage delivery and service performance and manage business risk within the scope of their product. Responsible for representing the product in governance boards such as Steering and Design Authority.
• Product/Project Delivery: Design and deliver the optimal set of products and services which meets the business strategy and requirements. Accountable for creation and execution of the product roadmap. May complete hands on configuration, providing detailed designs and wider impact assessments. The ability to think big picture and customer first is imperative.
• Quality, Risk & Compliance: Accountable for ensuring all products within the domain are compliant with internal security and risk management policies and practices, as well as external regulatory and statutory requirements e.g. GxP and that Tech continuity plans are in place for all critical products.
• Feature Definition: Proven ability to translate customer requests, competitive activities, and industry trends into value drivers of new technology solutions and product requirements that can be easily understood by product teams, developers and other key constituencies within the organization.
• Service Management: Responsible for ensuring any changes are delivered in accordance to the services levels that are in place, to ensure adherence to those SLAs, and directly managing any Level 3 support issues and escalations. Accountable for Lifecycle Management of the product.
• People Management: Will work in collaboration with the broader team to drive and deliver business value to tight timelines adhering to the release management calendar where applicable. Depending on team structure, the incumbent will matrix or line manage the team
• Adoption strategy & change management: in the role of change agent, support both the product teams and the business in agile approaches to solution development and adoption, building excitement, momentum, visible success stories and clear value based versions of vision as roadmap plans come to life

Why you?

Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:

* B.S. Degree – Technical degree or life sciences.

* Experience in pharma R&D setting with understanding of the clinical development process, phases of development, and decision frameworks for progressing biopharmaceutical assets

* Experience with Real World Data and Real World Evidence technologies and processes

* Track record in successful Tech strategy development, solution design, programme and product delivery, service and vendor management

* Track record in delivering business impact through process and Tech enabled solutions

* Excellent relationship management, strong influencing and communication skills

* Deep content knowledge of respective functional area (business operating models, processes & products)

* Knowledge and assessment of emerging trends (both functional and technical) within domain

* Experience and proven track record of working as part of agile development teams

* Experience with CFR 21 Part 11 compliance and good clinical practices.

* Strong facilitation, communication, and interpersonal skills, ability to influence sr. leadership and decision-making using data, market evidence

* Relentless for delivering business outcomes and value and simplification with a passion for science and advancing medicines to patients Preferred Qualifications: If you have the following characteristics, it would be a plus:

* Advanced Degree in computer science, management of information systems, or life sciences

Job Application End Date : 1st March 2024

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.