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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Acts as Lead Medical Writer on most types of writing projects
- Prepares assigned documents according to IQVIA SOPs, customer requirements, and agreed timelines
- Performs Senior Review of straightforward medical writing deliverables
- Negotiates timelines and discusses/resolves customer comments
- Provides written and verbal feedback to junior staff and customers when appropriate
- Keeps current with medical, technical writing, regulatory knowledge, and GCP developments
- Leads preparation of assigned documents, confirms scope, templates, specifications, timelines, reviews, and customer communication
- Plans and organizes workload, tracks timelines, and implements customer requests
- Leads meetings on challenging topics
- Presents Medical Writing processes at bid defense meetings
- Assists with training and development of junior staff and may deliver global team training
- May act as Project Manager for complex Medical Writing projects, including finance and invoicing responsibilities
- Completes project finance activities, including monitoring and forecasting budgeted hours
- Proposes, reviews, and approves routine project budgets and costings
- May take on customer lead responsibilities or assist partnership leads
- May represent the region or site on Medical Writing and cross-functional initiatives
- Facilitates identification of new ideas and may represent Medical Writing at capabilities audits
Requirements
What you’ll need- Bachelor's Degree in life sciences related discipline or related field
- Master's Degree in life sciences related discipline or related field
- Typically requires at least 5 years of highly relevant experience and related competency levels
- In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents
- 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
- Significant experience as a lead writer in preparing CSRs and protocols
- 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/technical writing skills
- Excellent attention to detail and accuracy
- Confident and effective communication and negotiation skills with customers and project managers
- Ability to manage multiple tasks and projects
- Must be computer literate