Principal Medical Writer

Responsibilities

• Ensure appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants as applicable.
• Manage clinical program documents for assigned clients, such as protocols, protocol amendments, investigator brochures (IBs), informed consent forms (ICFs), patient narratives, study reports, and more complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents).
• Lead cross‑functional coordination of resources to manage medical writing and QC deliverables.
• Independently author (write/edit) high‑quality medical writing deliverables across all phases of clinical research and in various therapeutic areas (protocols, amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, plain‑language summaries, and complex documents such as PBRER, IND, NDA, BLA, MAA, eCTD).
• Supervise, train, an...