Medical Writing is organized as a global group of around 100+ Medical Writing staff in the US, Brazil, India, Europe, South Africa, Ghana, Japan, China/Taiwan, Australia, and New Zealand.
The group mostly prepares study protocols and clinical study reports for Phase I–III interventional studies, covering a wide range of indications with oncology one of the most common. We also occasionally work on other documents such as investigator brochures, manuscripts and CTD summaries.
This role is home‐based and can be based anywhere in Australia.
Essential Functions
* Take a leading role in preparing assigned documents, including confirming scope, templates, negotiating timelines, organising document reviews, and communicating directly with the customer.
* Manage day‐to‐day workload: identify project needs, track timelines, implement customer requests, and keep manager/senior staff updated on progress and potential problems.
* Lead customer meetings independently.
* May give presentations to existing customers to discuss templates, results, lessons learned and respond to feedback.
* May deliver basic level training to small groups or individuals within IQVIA on the role of the medical writer, on medical writing processes, or on specific customer templates/processes and may provide guidance to more junior colleagues.
* May act as Project Manager for a small, short medical writing project.
* Complete project finance activities, including monitoring and forecasting budgeted hours.
* Understand budgets and project finance principles and interact with the Project Leader/Project Finance Manager on straightforward financial issues, increasing ability to estimate hours for routine tasks.
* May propose revisions to standard operating procedures (SOPs) or suggest process improvements for consideration.
Qualifications
* Minimum Bachelor's degree in a life‐sciences related discipline or related field.
* At least 3 years of experience in medical writing or relevant field.
* Proficiency in Japanese is a bonus.
* Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
* Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
* Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
* Ability to review a statistical analysis plan and identify deficiencies, errors, and inconsistencies in statistical output.
* Ability to integrate, interpret, and summarise data from a variety of sources in a clear and concise manner.
* Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.
* In‐depth knowledge of drug development, medical writing, and associated regulations; good understanding of statistical principles and medical terminology across therapeutic areas.
* Excellent written and oral communication skills, including grammatical and technical writing skills.
* Excellent attention to detail and accuracy.
* Communicates clearly, effectively and confidently with others.
* Demonstrated ability in collaboration with others and independent thought.
* Demonstrates confidence and maturity in 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.
* Ability to proactively identify potential issues/risks, consider solutions, and raise them with the customer, with senior guidance and input.
* Must be computer literate.
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. Learn more at https://jobs.iqvia.com
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