ICON
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Roles and Responsibilities
- Manages all aspects of the medical writing function.
- Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents.
- Contributes to clinical protocol development for first-in-human oncology studies.
- Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).
- Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents.
- Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers.
- Acts as a lead medical writer on complex programs and numerous individual studies.
Educations and Experience
- Advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 5 years of experience in a lead medical writing role in the pharmaceutical/CRO industry. *Note: Immunology experience is preferred but not required.
- Excellent writing skills.
- Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
- Knowledge of current requirements and guidelines applicable to submission documents.
- Excellent interpersonal and oral communication skills.
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
- Ability to prioritize multiple projects.
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.