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Medical Writer
2 weeks ago
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
Lead customer meetings independently
give presentation to an existing customer (eg to discuss templates, results, lessons learned), responding appropriately to feedback
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
also provide guidance to more junior colleagues
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 directly regarding straightforward financial issues, increasing ability to estimate hours needed for more straightforward/routine tasks
propose revisions to standard operating procedures (SOPs) or suggest process improvements for consideration
Qualifications
Bachelors Degree Bachelors Degree in life sciences related discipline or related field Req
Masters Degree Masters Degree in life sciences related discipline or related field
Pref
PHD PHD in life sciences related discipline or related field Pref
Typically requires at least 3 years of prior relevant experience and related competency levels
Req
Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents
Req
Ability to identify deficiencies, errors, and inconsistencies in a protocol or report
Req
Good understanding of common statistical methods used in clinical trials and/or interpretation of their results
Req
Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
Req
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
Req
Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues
Req
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
Req
Excellent written and oral 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
Ability to proactively identify potential issues/risks, consider solutions, and raise with the customer, with senior guidance and input
Must be computer literate
