Job Family Description
Writes, reviews, and coordinates technical documentation regarding clinical trials in line with client specifications and industry practices.
Sub-Family Description
Prepares, or contributes to the preparation of clinical and/or regulatory documents, for either internal customers or external clients, for investigational drugs, biologicals, or medical devices. Collaborates with internal and/or external experts and specialists; maintains expertise on developments in a particular field of focus.
Job Overview
Acts as a Lead Medical Writer on projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Negotiates timelines and discusses/resolves customer comments, with senior support as needed. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including GCP, along with developments and advances in drug development/medical and/or technical writing.
Essential Functions Take 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.Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.Attend project team meetings with or without other writers. Participate in/lead comments resolution or similar meetings with external customers.May give presentation to an existing customer (e.g. on processes at a Kick-off meeting).Complete project finance activities, including monitoring and forecasting budgeted hours.Awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.Qualifications B Sc Degree in life sciences related discipline or related field.Typically requires 1-3 years of prior relevant experience and related competency levels.Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.Ability 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.Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.Excellent written and verbal communication skills including grammatical/technical writing skills.Excellent attention to detail and accuracy.Communicates clearly, effectively and confidently with others.Demonstrated abilities in collaboration with others and independent thought.Demonstrates confidence and maturity in most routine medical writing situations.Demonstrates good judgement in requesting input from senior staff.Ability to establish and maintain effective working relationships with coworkers, managers and customers.Ability to effectively manage multiple tasks and projects.Must be computer literate.
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