Remote Job Opportunity: Medical Writer at IQVIA

IQVIA offers a remote job opportunity for the position of a medical writer, who will act as Lead Medical Writer on most types of regulatory writing projects. It mainly requires preparing 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; Will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in clinical drug development. For that, you should have experience authoring beginning-to-end Clinical Study Reports (CSRs) and Protocols.

You will be responsible for:

• 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, and 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.
• Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others.
• May input into and deliver presentations on Medical Writing to other IQVIA groups.
• 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 represent region or site on a Medical Writing initiative or cross-functional initiative.
• Facilitates and brainstorms the identification of new ideas.

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You must have:

• Bachelor's Degree in life sciences-related discipline or related field. Master's Degree and/or Ph.D. in life sciences-related discipline or related field is Preferred.
• Senior MW: Requires at least 5 years of highly relevant experience and related competency levels.
• Principal MW: Requires at least 7 years of highly relevant experience and related competency levels.
• In-depth knowledge of drug development, medical writing, and associated regulations.
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and the ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
• Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
• Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.
• 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 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. 

About IQVIA:

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. It believes in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

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