Senior/Principal Medical Writer - Regulatory (Remote)
Remote Opportunity - Located in the USA or Canada.
Please include a cover letter.
The Medical Writer will act as Lead Medical Writer on most types of regulatory writing projects; Will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements, per agreed timelines; Will perform Senior Review of straightforward medical writing deliverables, and negotiate timelines and discuss/resolve customer comments; Will provide written and verbal feedback to junior staff, and to customers when appropriate; Will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in clinical drug development.
*Candidates MUST have experience authoring beginning-to-end Clinical Study Reports (CSRs) and Protocols for interventional drugs.
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.
Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
Lead meetings on more challenging topics independently.
May present on standard Medical Writing processes at full-service bid defense meetings.
Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others. May develop and deliver training to the global team on a topic he/she has specific expertise in. May input into and deliver presentations on Medical Writing to other IQVIA groups.
May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.
Complete project finance activities, including monitoring and forecasting budgeted hours.
Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.
May take on a small customer lead role or assist an established partnership lead in their role.
May represent region or site on a Medical Writing initiative or cross-functional initiative.
Facilitates and brainstorms the identification of new ideas. May represent Medical Writing at a general capabilities audit.
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.
Senior MW: Requires at least 5 yearsof highly relevant experience and related competency levels, including acting as Lead Writer for Clinical Study Reports (CSRs) and clinical study Protocols.
Principal MW: Requires at least 7 yearsof highly relevant experience and related competency levels, including acting as Lead Writer for Clinical Study Reports (CSRs) and clinical study Protocols.
In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and 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.
Excellent written and oral communication skills including grammatical/technical writing skills.
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 attention to detail and accuracy.
Confident and effective communication and negotiation skills with customers and project managers.
Able to deliver difficult messages in constructive manner.
Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
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 evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.
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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