Be a part of a revolutionary change
At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products with the power to improve the lives of a billion smokers worldwide. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.
It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products.
Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers.
If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free future, your work could change the lives of a billion smokers.
Your ‘day to day’
Plan and execute data management workflow for pre-clinical studies and ensure that all necessary data quality control measures are in place. Coordinate with all laboratories, study and senior management to support regulatory submissions by using FDA-compliant systems.
• Coordinate and check the electronic data for non-clinical studies which may be used for regulatory submissions whilst ensuring compliance with relevant regulations.
• Review and develop documents for assigned studies, such as Study Plan, Study Endpoint Inventory List, Validation Specification, Data reviewers Guide and others as applicable or assigned.
• Manage the Non-Clinical Data Management databases to generate datasets and review for errors & warnings.
• Support the internal data clarification process which includes data validation checks & maintaining the data clarification log after receipt of the data from internal and external sources.
• Continuous improvement on documentations, such as data management plans, data validation plans, standard operating procedures, work instructions, and any others as required or requested in coordination with all applicable personnel.
• Implement and enforce regulatory requirements for the internal Standard Exchange Nonclinical Data (SEND) library so that data developed for regulatory submissions are compliant and correspond with the controlled terminology in the SEND Library. This includes acting as the subject matter expert to expand and maintain the SEND Library.
• Coordinate with study directors, study personnel, database programmers, regulatory and project management staff, and other relevant personnel to assure that the data management system and processes meet user and study requirements.
• Coordinate and document the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from external laboratories or Contract Research Organisations) including a seamless process to encompass this data for regulatory submissions according to the relevant external and internal guidelines.
Who we’re looking for
Bachelor's degree in Statistics, Science or Engineering with at least 2 years’ of related experience in a regulated environment, preferably in life sciences. We also welcome fresh graduates to submit their application. Strong initiative and organizational and communication skills with demonstrated capability of working on multiple projects at one time. Ability to complete deliverables on time and adjust priorities in a fast paced environment, and able to work independently as well as collaboratively in a team environment. Excellent verbal and written communications skills with experience working with MS Office Suite (Excel, Word and PowerPoint) and possess familiarity with MS Project. Experience working with Provantis and/or PathData is desirable and a plus.
What we offer
Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can:
• Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore.
• Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.
• Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress.
• Take pride in delivering our promise to society: to improve the lives of a billion smokers.
If you believe you would be a good fit to the requirements of the role, please submit your application online by 19 February 2020. Only candidates who fit the hiring requirements will be contacted. The successful candidate will be hired on the local employment terms and conditions in Singapore.