# Principal Medical Writer **Company**: IQVIA **Location**: Frankfurt, Hesse **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Frankfurt-Hesse-Germany/Principa-l-Medical-Writer---FSP--M-W-D-_R1577397?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_1257ed87-823 ## Description We are seeking a Principal Medical Writer to develop clinical documents for submissions to regulatory authorities globally. As a senior medical writer, you will provide strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. **Key Responsibilities:** - Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and client's authoring standards - Manage medical writing projects, including developing timelines and communication with cross-functional team members - Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents - Review other documents associated with the assigned project(s), as appropriate - Participate in cross-functional process improvement initiatives - Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents - Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects **Requirements:** - Bachelor's degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred - At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development - Proficiency in organizing and communicating clinical information required with minimal oversight - Strong organizational, time management, and project management skills are required - Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment - Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired ## Skills ### Required - medical writing - regulatory documents - project management - communication skills - global regulatory requirements ### Nice to have - advanced degree in a relevant scientific/clinical/regulatory field - knowledge of therapeutic areas in all phases of clinical development --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Frankfurt-Hesse-Germany/Principa-l-Medical-Writer---FSP--M-W-D-_R1577397?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)