Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.
The Sr. Medical Writer acts as a functional lead for medical writing projects and coordinating within and across departments. The successful candidate will manage all medical writing activities associated with individual projects and work independently on complex projects.
What you’ll do:
- Develops or supports a variety of documents including protocols, clinical study reports, patient narratives, IND submissions, integrated summary reports, annual reports, investigator brochures, clinical development plans, NDA and (e)CTD submissions, manuscripts, abstracts, client presentations. etc.
- Performs peer review/quality control (QC) of clinical study reports and other submissions written by other medical writers.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Identifies issues, and proposes solutions to resolve them during the writing process. Where required, escalate issues, as appropriate.
- Liaise with other functional groups (e.g. data management, statistical programming, biostatistics, project management, and publishing vendors) to ensure timely delivery and quality of writing deliverables.
- Keeps management informed on the progress of documents and other project-related activities, assists management in projecting efforts, and performs administrative duties as requested.
- Performs online clinical literature searches, as applicable.
- Stays aware of budget specifications for assigned projects, working within the budgeted hours, and communicating changes to medical writing leadership.
- Formulates writing strategy for key documents, including organization, content, timelines, and resource requirements; ensures that needs (e.g. headcount, funding, time) are appropriately represented to relevant teams and management.
- Prepares documents for submission to FDA or other regulatory agencies, ensuring consistency of content within the assigned submission or project and adherence to regulatory requirements and Cytel requirements and processes.
What you should have:
- Bachelor’s degree in life science or medical science-related discipline. Advanced degree (Master’s, Ph.D., MD, or local equivalent) a strong plus.
- 5 years of pharmaceuticals, biotech, or CRO medical writing experience.
- Working knowledge of drug development process, ICH, and other regulatory guidelines.
- Broad knowledge of global pharmaceutical regulatory requirements, and experience in clinical research or other areas of the pharmaceutical industry.
- Strong proficiency in Word, Excel, PowerPoint, email, and the Internet. and keen attention to detail also is required.
- Must have excellent verbal/written communication skills and excellent presentation skills
- Experience in medical content generation is preferred
- Excellent interpersonal and conflict resolution skills
- Ability to demonstrate familiarity with principles of clinical research, and to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner