Medical Writer / Sr Medical Writer
Job Type:
Regular Full-Time
Location:
Seattle, WA
Job Description:
Dendreon is seeking a Medical Writer who will lead the preparation of clinical reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration or other regulatory agencies. A self-motivated individual with strong oral and written communication skills is needed for this critical position.
General Summary:
Researches, writes and edits pre-clinical and/or clinical reports, summarizing data from pre-clinical and/or clinical studies.
Ensures the development of formats and guidelines for clinical documentation meet department standards.
Prepares scientific manuscripts, abstracts and posters.
Coordinates with clinical research associates and medical doctors in clinical protocol development.
Keeps abreast of professional information and technology through conferences.
Represents department in cross-functional teams, projects and GXP related problem resolution.
Job Requirements:
Bachelor’s degree in a scientific discipline or equivalent.
Typically a minimum of 5 years related experience in FDA regulated industry.
Knowledge of FDA and ICH guidelines.
Proficient in MS Office applications.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.