Medical Writer

Position Overview: Revelation Biosciences is seeking a mid-level Regulatory Medical Writer to develop high-quality clinical and regulatory documents supporting IND and NDA submissions across drug development programs. This role partners closely with Clinical, R&D, and Nonclinical teams to translate complex scientific data into clear, well-structured, and submission-ready documents. This is a remote-friendly position open to candidates able to collaborate across US time zones.

Duties and Responsibilities: Develop and execute strategic medical writing and scientific communication for Regulatory submissions including study reports, protocols and amendments,, and informed consent forms. Authors and revises documents that summarize cumulative safety and efficacy data for a compound, such as Investigator’s Brochures and periodic safety reports (PBRERs, DSURs, etc.).Prepares and revises materials that support regulatory submissions (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries).Collaborates with cross-functional teams for document preparation. Schedules and leads meetings, develops and tracks timelines, and oversees document review and comment resolution. Serves as the global medical writing representative at cross-functional team meetings (eg, study team, development team, and other subteams).Cultivates strong working relationships across functional groups to ensure stakeholder and customer needs are addressed. Offers peer review and editing assistance for additional regulatory documents, such as statistical analysis plans, CRFs, and other study materials. Supports the creation and review of standard processes and templates within global medical writing, and may consult on similar efforts in other departments. Comply with departmental policies and practices, along with technical and industry standards throughout all aspects of assigned projects. Performs other duties as assigned. Experience A minimum of 6 years' experience as a medical writer within the pharmaceutical industry – OR – a minimum of 10 years performing medical or scientific writing as a core job function.1) Medical Writing: Hands-on experience writing, reviewing, or editing protocols and clinical study reports is required. Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs is strongly preferred. Experience writing, reviewing, or editing regulatory briefing books is preferred. Experience writing, reviewing, or editing orphan drug designation requests and related regulatory submissions is highly preferred.2) Clinical Studies Strong grasp of the drug development lifecycle (from discovery through market), along with biostatistical and clinical research principles, study conduct, data collection, database management, data integration, and dataset generation. Moderate to strong understanding of scientific principles central to nonclinical development. Moderate to strong practical knowledge of:o documentation needed to conduct clinical studieso protocol design (including objectives, efficacy and safety endpoints, and processesfor capturing and reporting AEs and SAEs)o reporting of study resultso reporting of integrated results Hands-on experience with documentation across every phase of drug development.3) Regulatory Moderate to strong familiarity with the regulatory requirements and guidance governing standalone regulatory documents (eg. protocols, investigator brochures, and clinical study reports).Previous exposure to standard eCTD IND/NDA processes, including:o eCTD Modules 2, 3, 4, and 5 for INDs/NDAso Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)Education Bachelor’s of higher degree required; Scientific focus is a plus