Medical Writing Document Specialist 1

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Job Overview

Provides support to the Medical Writing business unit and Medical Writers in the preparation of Medical Writing deliverables and associated documentation. 

Essential Functions

• "Provide effective support to Medical Writing projects, as assigned, and take responsibility for on-time completion of tasks with high quality;
• Take responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff."
• Help identify quality issues and process improvement opportunities and bring awareness to senior staff;
• Comply with Company Standard Operating Procedures (SOPs) and participate in the implementation of new SOPs;
• Maintain awareness of regulatory guidelines, internal standards, and other requirements related to Medical Writing deliverables;
• May address technical issues with documents and applications and offer assistance to staff;
• Support the Medical Writing department in the collection of metrics;
• Provide support to Medical Writers in use of customers’ document management systems;
• Contribute to administrative elements of document preparation, under the direction of the Lead Medical Writer;
• Assist Medical Writers with electronic Trial Master File (eTMF) filing and related activities;
• Work directly and independently with the project team, customer, and/or third parties to confirm requirements and collect and compile Clinical Study Report (CSR) appendices in accordance with International Conference of Harmonization (ICH) guidelines and IQVIA standard practices, with limited guidance from the Lead Medical Writer;

Qualifications

• High School Diploma or equivalent High or Secondary School diploma/certificate or country’s educational equivalent
• 5 years' administrative experience in a pharmaceutical or medical research environment, with a good understanding of clinical drug development and the steps, processes, and functions involved
• "Careful attention to detail and accuracy;
• Ability to quickly establish and maintain effective working relationships with coworkers, managers and customers at a range of seniority levels."
• Confident use of Microsoft Office, Adobe Acrobat, and high comfort level in navigating document management systems and using new technology;
• Applies initiative in avoiding or solving problems;
• Ability to work on several projects at once while balancing multiple and overlapping timelines;
• Working knowledge of the nature and purpose of Medical Writing deliverables, and the nature, purpose, and source of contributing documents;
• Deep understanding of clinical drug development and the functions, steps, and processes involved;
• Ability to communicate clearly, concisely, and effectively in English, both in writing and verbally, and confidence in using a range of communication methods to achieve results;
• Proactive and advanced organizational and time management skills, with ability to prioritize workload effectively with commitment to deadlines;

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.