Commercial Lead(s) - Manchester, United Kingdom - Novacyt Group

Description

About Yourgene Health:
Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine.

Yourgene also has a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval and commercialise new products and services.

In addition, Yourgene offers and NIPT and high throughput Covid testing service.
Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada.

We have nay social and well-being initiatives run by our Social Huddle that keep our sense of community alive during challenging times that the pandemic has thrown our way.

Supporting Regulatory Affairs in the preparation of regulatory submissions to key territories (e.
The IVD Validation Team Leader will be anexpert who can provide scientific expertise, people leadership and technical leadership.

Ensures team people and skill development along with resource planning is effective and aligned with priorities set out by R&D management.

Working cross functionally to ensure that new and existing products continue to meet relevant regulatory requirements (e.g. Drives team forward and ensures work is well planned and executed to a high quality in a timely fashion. Team leadership and people management, as well as identifying strategic and tactical improvements to function

~ Effective short- and long-term resource planning, aligned against priorities and team member's skills

Project planning and reporting in collaboration with Project Leads;
Ensures project planning for work-packages within own area is performed effectively
Contribute to overall project planning while factoring in system level thinking
Ensuring verification and validation activities are planned and executed to ensure relevant regulatory requirements are met
Working with Regulatory Affairs in the preparation of Technical documentation to ensure successful regulatory submissions

~ Lead and participate in activities requiring cross functional collaboration, including leading complex projects

~

Validation:
Delivery of validated tests and systems for products and services in compliance of key regulatory requirements (e


Validation:
Review of technical documentation of existing products and planning of activities required to bring in line with new/updated regulatory requirements

~ Provides scientific expertise and technical leadership on projects

~ Ensure planning and reporting of studies, work-packages and other activities is accurate and detailed
Data generation, integrity and organized data management
Provide accurate and concise data interpretation, factoring in systems-level thinking
Meeting regulatory or other requirements

~ Ensure own work and that of junior staff is performed in line with company goals
Support and provide guidance to junior staff
R&D management, Team Leaders and other R&D team members

~ Quality, Business Development, Legal, Finance, HR, Admin

~ potential suppliers, commercial partners, etc


Supervisory/Management Responsibilities:
~ Line management of validation team members

Previous supervisory or line management experience
Knowledge of relevant regulatory requirements and preparation of associated technical documentation – in particular IVDR

~ Enthusiasm, drive, thoroughness, diligence and a willingness to take personal responsibility to ensure that projects are successful
~ Able to assimilate knowledge from technically detailed scientific sources

~ Can summarize complex scientific data in written form to effectively communicate plans, progress and ideas with Management, Peers or External Audiences

Good IT skills, including Microsoft Office suite
Sunday 24th March2024
Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce.