Associate, Medical Writing (MD)

Job description

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 an **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! The Medical Writer acts as a team member supporting and executing the creation and updating of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance Reports (SSCP), State of the Art Reviews (SOA) and Systematic Literature Reviews (LRR) for their assigned therapeutic area within Depuy Synthes. **Main Job Tasks and Responsibilities:** - Performs tasks according to the assigned medical writing activities including 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 Premarket Approval (PMA) Food and Drug Administration (FDA) Reports, including Humanitarian Device Exemption (HDE), Investigative Device Exemption (IDE) Reports, and Health Economics and Market Access (HEMA) research. The specific tasks are to be determined based on the assigned role in the project. - 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. - Proficiency in oral and written English language. - Proficiency in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint). **Education and Experience:** - Minimum bachelor’s degree in any life sciences field and at least 1 year of experience in medical writing, or any related field as applicable, OR - Advanced/Post graduate degree in Medicine or life science (i.e. Master’s in Public Health) with any professional experience. - Can work in a diverse team environment. - Good analytical and comprehension skills. - Proficient in time management and can work with minimal supervision. **Our Benefits:** - Flexible Working Hours - 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.