P&G MS Life Science Job Opening 2020 – Apply Online
P&G MS Life Science P&G is a leading global consumer goods company whose winning brands are built around the model of innovation. Whatever your passion is, we want to ignite your potential to become your very best self! We hold true to our purpose, values and principles as we seek to make a difference in the world around us. You will engage in meaningful work that will touch the lives of others and have a real impact.
Job Title: EMEA ORAL CARE REGULATORY & CLINICAL EVALUATION MANAGER FOR MEDICAL DEVICES
This regulatory and clinical evaluation role has two broad core responsibilities under the umbrella of compliance for European substance-based Medical Devices: management of registration dossiers and ongoing evaluation of the scientific data demonstrating the performance & safety of the products. The role covers existing products and future formulated products for our Oral Care business. You will interact with colleagues from various R&D subject areas & global locations as well as regulatory bodies.
P&G MS Life Science Job
- Clinical Evaluation for current and new medical devices. You will support the Clinical Evaluator by partnering with the Clinical Studies and methods groups to guide data generation plans for new devices in line with regulatory requirements & author the ‘Clinical Development Plan’ accordingly. You will design & analyse literature searches on the technologies used in the device, Summarise and update conclusions from these & any internal clinical studies, review findings from use of the device in the market & confirm the benefit-risk profile of the device meets the expectations.
- P&G MS Life Science You will document and organise this for use in the Clinical Evaluation Report. You will support the Clinical Evaluators in addressing questions from Regulators and monitoring emerging regulatory guidelines.
- Technical dossier management: You will partner with multidisciplinary colleagues in safety, microbiology, stability, manufacturing, packaging, post-market safety etc. to generate & maintain the dossier which summarises the technical data demonstrating compliance of the medical device with the legislation.
- You will ensure the dossier reflects technical changes & new regulatory requirements & lead responses to questions from the regulators.
Education: A minimum of a Masters’ degree in Life-Science (food chemistry, food technology, pharmacy, medicine, nutrition, etc.).
Languages: Proficiency in English.
P&G MS Life Science
- Ability to develop advanced skills in critical appraisal of data: Understand and summarize data from clinical studies, technical testing, literature reviews and evaluate it based on quality and relevance. You will need to then document this for external assessment
- Working in a highly regulated environment: Lead understanding of complex regulatory requirements and guide colleagues from other fields on these.
Strong attention to detail: Your documents you will share with regulatory bodies; it is paramount that they are accurate and that change control is effective and evident.
Strong project team leadership skills: You will own the development of regulatory dossiers which require multifunctional input.
- You will need to ensure the final dossier is ready and in line with project timings & to the required standard.
- P&G MS Life Science Both multidisciplinary AND depth approach: In the regulatory part of your role, demonstrate a broad approach- developing knowledge on all multidisciplinary information in the dossier by partnering with the relevant team members. In the Clinical Evaluation part of your role, demonstrate a depth approach; to personally maintain a knowledge of the ‘state of the art’ technology areas within your scope of responsibility & deeply penetrate the technical data used in the clinical evaluation reports.