OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personlaised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines.
Are you looking for a change in your career, are you an ambitious, talented and a motivated individual? This could be the role for you!
We are looking for an experienced Project Manager to join the Business Development function. This role is very hands-on and will be managing projects across the OGT offices in Cambridge and beyond. You will be responsible for project managing complex cross functional teams to deliver high quality products, many of them IVDs, to our customers These will play an important part in driving improvements in our understanding of genetic diseases and the goal of ultimately improving patient care.
Your duties will include:
- Work closely with R&D, Marketing, Quality/Regulatory, Medical Affairs and Production on the planning and execution of diagnostic development projects and product/process change projects
- Lead cross-functional project teams to deliver projects to agreed scope, cost, quality and timeline
- Organise and lead regular project team meetings ensuring timely completion of tasks
- Analyse, plan and track project activities, communicating progress against plan on a regular basis to all relevant stakeholders, including maintaining decision logs, meeting minutes, timelines and shared documentation
- Ensure programme governance process is adhered to with formal documentation and reporting
- In conjunction with key stakeholders ensure project files are maintained to support the quality management system, particularly for the Quality System Regulation requirements of 21 CFR 820 and ISO 13485
- Identify and efficiently resolve or escalate issues and risks to stakeholders in a timely and clear fashion
- In conjunction with relevant stakeholders identify resources required and manage these for all projects. With Head of PMO, manage resourcing, dependencies and interfaces between projects.
- Track estimated project costs and proactively communicating deviations to relevant stakeholders
- Apply project management tools and methodologies to ensure cross-functional alignment and accountability
- Develop positive relationships with internal teams and stakeholders
- Work with internal teams to ensure smooth transition to business as usual as the projects conclude and conduct lessons learned evaluations and guidance at the point of handover
- Evaluate and propose activities and interventions where innovation or best practice becomes an opportunity for improvement within budget and agreed timelines.
What we’re looking for in you:
- BSc and MSc or other post-graduate level qualification in life or medical sciences
- Experience and expertise
- Strong scientific knowledge and good understanding of genomics and genetic diagnostics
- Good understanding of Project Management principles, concepts, practices and standards
- Managing diagnostic development projects in either the pharmaceutical or diagnostic industry
- Managing new product development processes within ISO 13485 as well as 21CFR 820 compliant quality systems
- Experience of development of IVDD/IVDR products, particularly experience with FDA Pre-Market Approvals (PMA) and Notifications (510(k))
- Managing project level budgeting, contracting and financial controls
- Strong presentational skills, including communicating to senior stakeholders internally and externally
- Ability to create and lead highly motivated cross functional teams to deliver successful projects
- Building trusted, influential relationships with senior stakeholders that facilitate effective decision making and project execution
- Strong analytical skills with a proven ability to balance and prioritize responsibilities in accordance with business and team needs
- Engaging with technical teams to ensure effective solutions to design and development challenges
- Maintain team focus on quality while adhering to project timelines and goals
- Confident user of digital project and team management tools for planning, communication, activity tracking and reporting.
- Certification of competence in a recognised project management framework e.g. PMP
- Experience of clinical trials of pharmaceutical products would be advantageous.
In return you will receive:
- Competitive salary
- Pension Scheme (10% non-contributory)
- Private Health Insurance
- Private Dental Insurance
- Group Income Protection
- Group Life Assurance
- 25 days holiday plus UK bank holidays
- High Street Discount Scheme.
Application is via CV & a one-page covering letter outlining your suitability for the role, salary expectations and notice period
Please note that we will need to establish your right to work during the recruitment process.