Job Specifications
ABOUT ORGANOX:
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company's first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.
Position Summary
The position of Program Manager will ensure that designated programs are managed utilising the key Project Management competencies of scope, planning, budgeting, quality, risk, resource planning, communication, and collaboration to successfully complete strategic organisational programs.
The Program Manager will develop, streamline, and nurture key relationships with project stakeholders at all seniority levels, promoting alignment and championing the values of OrganOx.
This role sits within the OrganOx PMO which supports project portfolios across all business functions.
Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.
This is an on-site role in Oxford with flexibility.
Major Responsibilities
Under direction from the Head of PMO, the Program Manager will be responsible to:
Work collaboratively with the Functional Directors to plan, direct and coordinate activities of assigned program/project resources to ensure that objectives of projects are accomplished within prescribed scope, time, and cost parameters
Collaborate with the Regulatory Affairs and Quality teams to certify adherence to necessary standards (i.e. ISO 13485, 14971, EN 60601, MDR(EU)2017/745) and to uphold the Quality Management System
Management of project and program core teams, driving cross functional alignment and execution
Maintain project, program, and portfolio management governance structures to ensure consistency of approach and current best practice is utilised
Seek stakeholder insight and feed into improved processes while ensuring compliance with governance structure and standards
Manage relationships amongst stakeholders by building confidence and trust with clear professional communications and assured expectation management
Generation and management of Program/Project Work Packages; including (but not limited to) project charter, financial needs assessment, financial budget, change control, project risk assessment, project plan, resource loading plan, stakeholder analysis, and communication plan
Generation and presentation of program/project Scorecards to communicate Project Key Performance Indicators (KPI) to Senior Leadership Team (SLT)
Review resource loading plans with Functional Directors. Work with Functional Directors to determine mitigation actions in the event of resource constraints
Provide program/project summaries for subsequent presentation to the C-suite
Review monthly forecast and budget adherence with the Financial Controller. Report adverse financial deviations immediately
Conduct reviews to assess project outcomes and to identify and capture lessons learned to enable continuous improvement
Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies
Requirements
Skills & Experience
Strong & proven experience in direct project/program management experience in Medical Device or Pharmaceutical Industries or equivalent
A proven track record in managing medical device design and development projects, working within ISO 13485, IEC 60601, and risk management processes of ISO 14971
Experience of Digital and SAMD development within IEC 62304
Excellent communication and leadership skills, commercially astute with the ability to negotiate with suppliers and multi-functional internal stakeholders
Ability to lead and manage multi-functional project teams effectively without direct authority
Good working knowledge of standard office, project management and engineering software
Excellent financial management skills with experience managing multiple project budgets simultaneously
Experience in the management of teams both face to face and remotely through appropriate collaboration platforms and project management systems
Positive "can do" attitude; identifies problems, provides/facilitates the creation of options and recommendations and uses initiative to drive solutions
Multitasker - be able to juggle priorities across multiple needs
Has a solution focused, pragmatic approach
Confident communicator with ability to tailor style and content to the needs of the audience
Developed emotional intelligence, remaining calm under pressure and takes ownership for delivering outcomes
Shows commitment to professional development; demonstrates enthusiasm, willingness and ability to learn new skills.
Creates momentum and excitement around initiatives and new approach
About the Company
"Living Organs For Life"
Transforming transplantation with the OrganOx metra®. A transportable, automated ex vivo liver perfusion device.
The core technology employed by the OrganOx metra® has been in development for over 15 years. During this time both of the founders (Professor Peter Friend and Professor Constantin Coussios) have driven the development of organ preservation and maintenance, formerly at the University of Cambridge and latterly at the University of Oxford.
OrganOx Limited was founded in April 2008 as a spi...
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