Senior Medical Writer

Job OverviewActs as Lead Medical Writer on most types of writing projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs Senior Review of straightforward medical writing deliverables. Provides written and verbal feedback to junior staff, and to customers when appropriate. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing. Essential FunctionsTake a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer. Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests. May present on standard Medical Writing processes at full-service bid defense meetings. Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others. May develop and deliver training to the global team on a topic he/she has specific expertise in. May input into and deliver presentations on Medical Writing to other IQVIA groups. May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities. Complete project finance activities, including monitoring and forecasting budgeted hours. Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks. May represent region or site on a Medical Writing initiative or cross-functional initiative. May represent Medical Writing at a general capabilities audit. QualificationsBachelor's Degree Bachelor's Degree in life sciences related discipline or related fieldMaster's Degree Master's Degree in life sciences related discipline or related fieldPh.
D. in life sciences related discipline or related field PrefTypically requires at least 5 years of highly relevant experience and related competency levels. In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report. Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical outputAbility to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. In depth knowledge of drug development, medical writing, and associated regulations. Excellent written and oral communication skills including grammatical/technical writing skills. Confident and effective communication and negotiation skills with customers and project managers. Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges. Demonstrates good judgement in requesting input from senior staff. Ability to effectively manage multiple tasks and projects. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.