Principal Medical Writer leading CMC regulatory submissions for Veristat’s life - sciences clients. Authoring Modules 3 and 2.3 while guiding project teams and mentoring regulatory writers.
About the role
- Lead Medical Writer preparing clinical study reports, protocols, and regulatory documents for IQVIA’s global clinical research business. Leading reviews, client communication, project timelines, budgets, and junior-writer development.
Responsibilities
- Act as Lead Medical Writer on most types of writing projects
- Prepare assigned documents according to IQVIA SOPs, customer requirements, and agreed timelines
- Perform senior review of straightforward medical writing deliverables
- Negotiate timelines and discuss and resolve customer comments
- Provide written and verbal feedback to junior staff and customers when appropriate
- Keep current with medical and technical writing, regulatory knowledge, GCP, and advances in drug development
- Lead preparation of assigned documents, confirming scope, templates, specifications, timelines, reviews, and customer communication
- Plan and organize workloads, identify project needs, track timelines, and implement customer requests
- Independently lead meetings on challenging topics
- Present standard Medical Writing processes at bid defense meetings
- Train and develop junior staff; develop and deliver specialized training to global teams
- Contribute to and deliver Medical Writing presentations to IQVIA groups
- Potentially manage complex, standalone Medical Writing projects, including project finance and invoicing
- Monitor and forecast budgeted hours
- Propose, review, and approve budgets and costings for routine projects
- Potentially take on a small customer lead role or assist an established partnership lead
- Represent the region or site in Medical Writing or cross-functional initiatives
- Facilitate brainstorming and the identification of new ideas
- Potentially represent Medical Writing during a general capabilities audit
Requirements
- Bachelor's degree in a life sciences-related discipline or related field required
- Master's degree in a life sciences-related discipline or related field preferred
- Ph.D. in a life sciences-related discipline or related field preferred
- Typically requires at least 5 years of highly relevant experience and corresponding competency levels
- In-depth knowledge of clinical study reports, protocols, and similar documents
- Ability to identify deficiencies, errors, and inconsistencies in protocols, reports, and statistical outputs
- Good understanding of common statistical methods used in clinical trials and/or the interpretation of their results
- Ability to review statistical analysis plans
- Ability to integrate, interpret, and summarize data from varied sources clearly and concisely
- Significant lead-writer experience preparing CSRs and protocols, with consistently positive feedback from customers and colleagues
- In-depth knowledge of drug development, medical writing, and associated regulations, including GCP
- Good understanding of statistical principles and medical terminology across therapeutic areas
- Excellent written and oral communication skills, including grammatical and technical writing skills
- Excellent attention to detail and accuracy
- Confident communication and negotiation skills with customers and project managers
- Initiative, sound judgment, collaboration, independent thought, and maturity
- Ability to establish effective working relationships with coworkers, managers, and customers
- Ability to manage multiple tasks and projects
- Ability to assess risks and potential issues, identify solutions, and discuss them appropriately
- Must be computer literate
Benefits
- Incentive plans, bonuses, and/or other forms of compensation may be offered
- Health and wellness benefits
- Other benefits
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