IVD and Regulated Biomarker Expert

Job description

The Position

In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. We are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

This position is located in the Regulatory Bioanalysis and Biosample Operations chapter within PS, which is accountable for developing efficient End 2 End (E2E) patient centric biosample strategies, ensuring maximum utilisation for every sample comprising PK, immunogenicity, safety and PD (soluble target & biomarkers) endpoints. Additionally ensures assay readiness, data context enabling decision making and ultimately deliver robust and fit for purpose BioX regulatory filings.

Your key responsibilities & impact

As IVD & Regulated Biomarker Expert, you'll be pivotal in ensuring compliance with IVD and biomarker regulations, supporting the implementation of IVDRs for all required assays, and developing strategies to ensure that products meet all relevant standards and regulatory requirements. 

• Develop IVD strategies within Roche pRED to ensure that products comply with relevant regulatory standards.

• Act as the pRED representative on internal and external IVD infrastructure work streams and discussions.

• Analyse and interpret technical data pertaining to any IVD-related regulations.

• Review protocols and other relevant documents and guide project teams in all aspects of IVD required for the project.

• Review and contribute to documents for regulatory submissions; support filings and answer any questions about IVD coming from the regulatory agencies.

• Advise teams when biomarker assays used in clinical trials for medical purposes - including patient management and routine diagnosis

• Implement, roll out and train pRED personnel on IVD implementation strategies, regulations, and processes.

• Collaborate closely with other scientists and regulatory professionals to ensure compliance with all relevant regulations.

• Provide guidance and support to research teams, as needed.

• Monitor developments in the field of IVD regulations and provide updates to relevant stakeholders, keeping up-to-date on the latest requirements, trends, and changes in IVD regulations, disseminating information across stakeholders and ensuring avoidance of over interpretation

Your profile

• You hold a PhD or MSc degree in a scientific discipline as well as solid experience working in industry conducting analyses related to IVD (in vitro diagnostics) regulations.

• You have excellent analytical, research, problem solving skills and excel at critical thinking. 

• You engage in constructive challenges and collaborations to expedite progress for patients. You excel in simplifying processes and identifying priority areas that directly impact patients, while also discontinuing non-essential tasks.

• Leading alignment with stakeholders, you foster collaboration.

• Additionally, you contribute to a culture of ownership & accountability by actively seeking and providing feedback.

• You are based in one of the available site locations, Welwyn, Basel or Penzberg.

Your application

Please upload your current compelling CV & cover letter. We look forward to seeing your application!

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.

Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.