IQVIA Clinical Study Report and Protocol Medical Writer 2 in Saskatoon, Saskatchewan
Medical Writer 2
Candidates, please include a cover letter.
The Medical Writer 2 will act as Lead Medical Writer on more advanced regulatory writing projects (e.g. complex clinical study reports, protocols, more challenging indications, or customers); Will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements per agreed timelines; May provide feedback to peers when asked for input or review; Will negotiate timelines and discuss/resolve customer comments; Will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in clinical drug development.
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.
May give presentation to an existing customer (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 directly regarding straightforward financial issues, increasing ability to estimate hours needed for more straightforward/routine tasks.
May propose revisions to standard operating procedures (SOPs) or suggest process improvements for consideration.
Bachelor's Degree in life sciences related discipline or related field is Required; Master's Degree and/or Ph.D. in life sciences related discipline or related field is Preferred.
Typically requires at least 3 years of prior relevant experience and related competency levels, including acting as lead writer for clinical study reports and clinical study protocols.
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 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.
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 of medical terminology across a range of therapeutic areas.
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.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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