Medical Writer 2 – IQVIA, Adelaide, South Australia, Australia
Medical Writing is organised as a global group of approximately 100+ staff across the US, Brazil, India, Europe, South Africa, Ghana, Japan, China/Taiwan, Australia and New Zealand. The team prepares study protocols and clinical study reports for Phase I‐III interventional studies, most commonly in oncology, and occasionally works on other documents such as investigational plans (IBs), manuscripts and CTD summaries. This role is home‐based and can be performed from anywhere in Australia.
Essential Functions
* Take a leading role in preparing assigned documents, including confirming scope of task, confirming templates and specifications, negotiating and adhering to 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 abreast of progress and any potential problems.
* Lead customer meetings independently.
* May give presentations to existing customers (e.g., to discuss templates, results, lessons learned), responding appropriately 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; may also provide guidance to more junior colleagues.
* May take the role of Project Manager for a small and short Medical Writing project.
* Complete project finance activities, including monitoring and forecasting budgeted hours.
* Understand budgets and project finance principles; interact with Project Leader/Project Finance Manager regarding straightforward financial issues, increasing ability to estimate hours needed 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 experience.
* 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 effectively 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 a range of 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 abilities in collaboration with others and independent thought.
* Demonstrates confidence and maturity in most routine medical writing situations.
* Demonstrates good judgement when 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.
Senior level: Mid‐Senior level
Employment type: Full‐time
Job function: Marketing, Public Relations, and Writing/Editing
Industries: Hospitals and Health Care
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