The Medical Information Specialist (MIS) performs literature screening and extraction/appraisal of the data which are further used for drafting systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER)/Summary of Safety Clinical Performance (SSCP), Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR), and Pre-Market Approval (PMA) Food and Drug Administration (FDA) Reports, including Humanitarian Device Exemption (HDE) and Investigative Device Exemption (IDE) reports.
The MIS works closely with other MISs and Medical Writers (MW). Responsibilities:- Follows the screening and extraction assumptions and instructions provided in the protocol and the data collection software forms (e.g. Distiller).
- Participates in kick-off meetings (KO) organized by the MWs and clarifies all the questions regarding screening and extraction of the literature.
- Utilizes software for screening and extraction (e.g. Distiller, Microsoft Excel).
- During 1 working day (8 hours), screens from 80 to 100 references.
- Downloads full-text English PDF files of all included publications and sends to the relevant franchise’s Complaint Handling Unit (CHU) within 24 hours of screening.
- During 1 working day (8 hours), extracts from 8 to 10 included publications or re-extracts from 15 to 18 previously extracted publications (as applicable).
- Performs Quality Control (QC, 10-12 per 1 working day) of data extracted by other MISs or MW using software (e.g. Distiller) followed by Conflict Resolution (CR).
- Maintains ongoing contact with MW and other MISs for clarification of any further questions that arise during the literature screening and data extraction/re-extraction, QC, CR process.
- Demonstrates an understanding in assigned therapeutic areas, provides expertise in device technology, interprets clinical research methodology and study design, ensures compliance with medical device regulations globally, and escalates any new or emerging risks.
- Responsible for identification and analysis of clinical evidence for the underlying health problem to be treated with intervention involving the subject device(s), alternative therapeutic options for the clinical problem, and current interventions/therapies for the intended population (diagnoses or management) for consideration in the risk/benefit assessment of the subject device.
Our Benefits:
• Daily Meal Subsidy
• Flexible working hours and work from home privileges.
• HMO coverage up to maximum of 2 dependents subsidy
• Life and accident Insurance
• 15 Sick Leave and 15 Vacation Leave
• Monetized leave
• Performance Based Annual Salary Increase
• Clothing Allowance
• Rice Allowance
• Laundry Allowance
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
ClinChoice is an Equal Opportunity Employer / Committed to Diversity
