Oro Clean Chemie Sdn Bhd is looking for an experienced Clinical Medical / Technical Writer to assist the R&D team in the preparation of technical documents that support regulatory submission
Main Duties & Responsibilities
Prepare and review regulatory submission documents ie Clinical Evaluation Reports and Risk Management ReportsLiaise with regulatory authorities ie Notified Bodies to ensure documents meet current regulatory requirements as well as internal and external guidelinesParticipate in Post-Market Surveillance (PMS) activities by conducting routine systematic literature reviews, product complaint reviews and other product specific information reviews ie screen articles / literature against specified inclusion / exclusion criteria, extracts relevant data from included studies, interpret study results and prepare summary reports
Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Master's Degree, Doctorate (PhD), Dentistry, Medicine, Medical Science, Pharmacy/Pharmacology, Biomedical Science or equivalentIdeally 2 years medical or technical writing experiencePrior experience in preparing Clinical Evaluation Reports, Risk Management files or PMS is an advatageExcellent technical writing skills in EnglishMust possess high level of accuracy and attention to detailsIndependent and self-driven individual with the ability to prioritize and handle multiple projects simultaneously with a focus on resultsAbility to contribute to continuous quality improvementA self-starter who can work on own initiative without constant supervision
Salary:MYR 4,000 - 6,000
Deadline:07th Mar 2020
Over 45 Years Experience of Researching and Producing Disinfectants
OCC Switzerland is a research-driven manufacturer of high-quality disinfecting and cleaning products. Our slogan ‘killing germs for a safer world’ describes our long-standing mission to support healthcare professionals such as infection control preventionist, doctors, nurses, dentists, veterinarians, beauticians
and other professionals in their continuous battle to prevent the spread of disease. We do so by offering fast-acting, reliable and safe disinfectants.
Since OCC Switzerland’s foundation in 1969, the company has pioneered many breakthroughs in the field of infection control. In 1986, we were the first Swiss company who developed a fast-acting, safe instrument disinfectant which was effective against the Hepatitis B virus (HBV). In 1991, concerned about the high risks of disease transmission associated with the use of turbines, hand-pieces, and contra-angles, OCC Switzerland in collaboration with Dr. Guggenheim, a professor from the University of Zurich, developed a disinfectant to be used in a cutting edge device designed to clean and disinfect this type of instruments. And once again, in 1996, we became the first Swiss dental company to be certified EN 46001 and 93/42/EEC.
More recently, we have developed a new generation of surface disinfectants reducing the alcohol content to less than 50 %. We have done so without compromising the disinfectant’s effectiveness. This new generation of products offers not only full virucidal activity and optimal material compatibility but also significantly reduces the potential for allergic reactions.
Since our early days, our goal has been to manufacture innovative, environmentally sensitive products with a broad spectrum effect and high material compatibility maximizing protection against disease transmission. This philosophy has remained unchanged. However, our product range and services have evolved in response to market and consumer demands. Subsequently, the effectiveness of our disinfectants is continually adapted in order to inactivate emerging pathogenic microorganisms.
We are proud of our past and present achievements; however, what really excites us is the future. We are pursuing the research and development of new products and devices expanding the base of effectiveness, reducing exposure times and increasing compliance with infection control procedures. Our goal is to work toward the day where diseases no longer pose a threat and health care related infections are non-existent.
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