Purpose

Develops within the medical writing role within the pharmaceutical industry. Works in a team environment and matrix. Performs routine tasks per established procedures. Gains knowledge and applies internal standards, regulatory, and publishing guidelines. With increasing skill, uses internal systems, tools, and processes. Writes and coordinates basic documents, preparing more complex documents (within the TA and across TAs) in accordance with experience level. Functions as a lead writer on a project, indication, or a compound either early- or late-stage in life cycle under close supervision. Participates in process working groups.

Responsibilities

• Writes and coordinates basic clinical documents such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writes, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as, but not limited to, Ph...