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 an Associate, Medical Writing (MD) on a permanent basis. 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.

Responsibilities

Performs 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) FDA Reports, including Humanitarian Device Exemption (HDE), Investigative Device Exemption (IDE) Reports, and Health Economics and Market Access (HEMA) research; Alerts and escalates to senior members whenever project deliverable risks or issues impacting the delivery schedule are identified; Ensures error free and acceptable quality of assigned deliverables; Ensures training compliance and timesheet compliance; Ensures assigned goals (e.g., utilization and efficiency) are met; Follows the Company's Code of Conduct, Policies, and Procedures; Responsible for confidentiality, integrity, availability, and safeguarding of data; Reports security incidents and PIMS breaches as applicable; Complies with company QMS, ISMS, PIMS and applicable regulatory requirements; Demonstrates adherence to PIMS/GDPR requirements

Requirements

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; Proficiency in oral and written English language; Proficiency in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint); Can work in a diverse team environment; Good analytical and comprehension skills; Proficient in time management and can work with minimal supervision

Benefits

Flexible Working Hours; Team events and end of year party; Employee satisfaction survey; Health Insurance