Medical Information Specialist /Associate - Medical Writing (MD)

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Medical Information Specialist /Associate - Medical Writing (MD) on a permanent basis.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Position Overview:
The Medical Information Specialist (MIS) executes assigned data screening and data collection activities to support systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), State of the Art (SOA), 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.

Main Job Tasks and Responsibilities:

• Follows the screening and data collection instructions provided by the Medical Writer in the literature review protocol and the data collection plan,

• Utilizes available software tools (e.g., Microsoft Excel) for screening and data collection of literature,

• Complies with the metrics (volume of tasks completed per day/project) and timelines provided by the client, as applicable,

• Collaborates with, and maintains ongoing communication with, the Medical Writer and other Medical Information Specialists for clarification of questions that arise during the project kickoff and throughout the screening and data collection process to ensure quality standards of deliverables are met.

• Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues are encountered impacting the delivery schedule,

• Ensures error free and acceptable quality of assigned deliverables,

• Responsible for ensuring training compliance and timesheet compliance,

• Ensures that all assigned goals (e.g., utilization and efficiency) are met as per set standards for the performance year,

• Follows and complies with the Company’s Code of Conduct, Policies, and Procedures,

• Responsible for confidentiality, integrity, availability, and safeguarding of data,

• Responsible for reporting of security incidents and PIMS breaches as applicable,

• Complies with company QMS, ISMS, and PIMS requirements and applicable regulatory requirements,

• Demonstrates adherence and compliance to PIMS/GDPR requirements as follows: data processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner.

Education and Experience:

• Minimum bachelor’s degree in any life sciences field,

• 1-5 years of experience in medical writing, or any related field as applicable,

• Can work in a diverse team environment,

• Good analytical and comprehension skills,

• Proficient in time management and can work with minimal supervision,

• Proficiency in oral and written English language,

• Proficiency in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint).

Our Benefits:

• Flexible Working Hours

• Full performance and development process with end of year reviews

• Team events and end of year party

• Employee satisfaction survey - your feedback is important for continuous improvement

• Health Insurance

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.