Yoh has multiple opportunities for Medical Writers to assist our customer, a global pharmaceutical company, with many new projects.
This is an on-site contract assignment slated to last one year. Chosen candidates will be asked to complete a writing exercise prior to a phone interview.
Job Details:
The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents) across product life cycle to ensure timely registration.
Major Responsibilities:
- Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
- Critically assesses, interprets, and accurately summarizes medical data.
- Contributes to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
- Promotes and exploits global working in the preparation of clinical contributions to regulatory dossiers.
- Provides innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
- Interprets and monitors current and emerging communication issues and guidelines.
- Manages contract resources through the effective use of project management skills to ensure the delivery of quality documents.