Senior Medical Writer

🔥 0 minutes ago

🇨🇦 Canada – Remote

đź’µ $99.5k - $132.6k / year

⏰ Full Time

đźź  Senior

🏥📝 Medical Writer

đź‘» Ghost score 0%

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🗣️🇫🇷 French Required

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IQVIA

10,000+ employees

đź’Ľ Consulting

🏭 Manufacturing

📣 Marketing

đź’° $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

đź“‹ Description

• 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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