The Medical Writer participates as a member of clinical teams and serves as team specialist in matters pertaining to clinical documentation. The medical writer leads the documentation process and ensures compliance to FDA reporting requirements.
- Prepares, edits and reviews clinical documents with guidance from Clinical Research, Biostatistics, Regulatory Affairs and Drug Safety
- Prepares templates and documents for pre-IND/IND/NDA/BLA applications according to requirements and regulations
- Assists in the preparation of manuscripts, abstracts, posters, and reviews articles, as needed
- Leads the documentation process and ensures compliance to FDA reporting requirements
- Serves as a team specialist for clinical documentation, including quality, resource requirements, and scheduling
- Reviews and edits documents for organization clarity, use of English language/grammar, and scientific standards
- Resolves errors and inconsistencies in clinical data with Biostatistician and other project team members, as necessary
- This position requires a Master's degree in a biological science or pharmacy; Ph.D. preferred
- This position requires a minimum of 3 years in regulatory medical writing for a pharmaceutical, biotechnology or contract research company/university medical center, and an understanding of clinical regulatory documentation requirements
- Must demonstrate a clear, high quality scientific writing style in the English language, and have the ability to independently analyze and synthesize data from a broad range of disciplines
- Must be proficient with Microsoft Office applications
- Must be organized, have the ability to successfully manage multiple projects from conception to completion, be able to work in a team environment, and communicate effectively in a fast-paced setting.
- Able to read and understand peer reviewed, scientific literature in the field of immunology as it relates to monoclonal antibodies. Able to evaluate and comprehend graphs of scientific data. From the data reviewed and literature read, able to synthesize reasonably comprehensive, first draft documents to be incorporated into FDA submissions and/or scientific manuscripts.
Discover all that's possible with Yoh. Apply now.
Recruiter: Lauren Entler
Phone Number: 215-299-8088
Deadline: Contact employer