Medical Writer

Company Description

Revelation Biosciences, Inc. is a clinical-stage biotech company dedicated to restoring immune balance by targeting inflammation through its proprietary Gemini formulation. The company is advancing a diverse pipeline of programs evaluating Gemini across multiple indications, including the treatment of chronic kidney disease, prevention of post-surgical infections, and management of acute kidney injury.

Find out if this opportunity is a good fit by reading all of the information that follows below.

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 studies

o protocol design (including objectives, efficacy and safety endpoints, and processes

for capturing and reporting AEs and SAEs)

o reporting of study results

o reporting of integrated results

• Hands-on experience with documentation across every phase of drug development. xxzpjkt

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/NDAs

o Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)

Education

• Bachelor’s of higher degree required; Scientific focus is a plus