Full-time, Permanent, 100% Remote Opportunity
Summary: The Principal Medical Writer will act as the lead medical writer on many types of writing projects at a leading global clinical research organization (CRO), including many projects with multiple deliverables or components in accordance with company Standard Operating Procedures (SOPs). You will also perform senior review of many types of medical writing deliverables as well as provide feedback and guidance to more junior writers. If you are a medical writer looking to work at one of the world's largest and most prominent CROs, please see below.
The Principal Medical Writer will be responsible for:
- Taking the lead when preparing assigned documents, including confirming the scope of the task, confirming templates and specifications, negotiating and adhering to customer timelines, organizing document reviews and communicating directly with customers.
- Possibly drafting new SOPs for review and act as reviewer for new SOPs
- Utilize industry experience and drive to take on new or unusual document types as needed
- Create and organize project and task workloads according to project needs, timelines and customer requests
- Participate in project finance including monitoring and forecasting budgeted hours as well as independently proposing, reviewing and approving budgets and assumptions for different project types
- Acting as Project Manager or taking on a partnership lead role
- Generic training of junior staff including design and implementation of training materials
The Principal Medical Writer should have the following qualifications:
- Bachelor's Degree in life sciences or related discipline or related field is required; Master's Degree and/or Ph.D. in life sciences related discipline or related field is preferred
- At least 7 years of highly relevant experience, including extensive experience in preparing clinical study reports (CSRs) and protocols independently to a high standard
- Understanding of common statistical methods used in clinical trials and the interpretation of their results
- Knowledge of drug development, medical writing and associated regulations and an understanding of medical terminology across a wide range of therapeutic areas
- Capability to integrate, interpret and summarize data from a variety of sources in a clear and concise manner
- Be a part of progressive clinical trials with the capacity to create a healthier world
- Exposure to a variety of therapeutic areas
- 100% remote opportunity
If you are interested in the Principal Medical Writer role, then please don't wait to apply!