Medical reputed company

reputed company Revelation Biosciences, Inc. is a reputed company-stage biotech company dedicated to restoring immune reputed company by targeting inflammation through its proprietary reputed company formulation. reputed company is advancing a diverse pipeline of programs evaluating reputed company across multiple indications, including the treatment of chronic kidney disease, prevention of post-surgical infections, and management of acute kidney injury. reputed company Revelation Biosciences is seeking a mid-level Regulatory Medical reputed company to reputed company high-reputed company reputed company and regulatory documents supporting IND and NDA submissions across drug development programs. This role partners closely with reputed company, R&D, and Nonclinical teams to translate reputed company scientific data into reputed company, reputed company-reputed company, and submission-reputed company documents. This is a remote-friendly position reputed company to candidates reputed company to collaborate across US time reputed company. Duties and Responsibilities • reputed company and execute reputed company 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 reputed company 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 reputed company. • 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 reputed company 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 reputed company processes and templates reputed company global medical writing, and may reputed company on similar efforts in other departments. • reputed company with departmental policies and practices, along with technical and industry standards throughout reputed company aspects of assigned reputed company. • Performs other duties as assigned. Experience • A minimum of 6 years' experience as a medical reputed company reputed company the pharmaceutical industry – OR – a minimum of 10 years performing medical or scientific writing as a reputed company job function. 1) Medical Writing: • Hands-on experience writing, reviewing, or editing protocols and reputed company 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 reputed company regulatory submissions is highly preferred. 2) reputed company Studies • Strong grasp of the drug development lifecycle (from discovery through market), along with biostatistical and reputed company research principles, study conduct, data collection, database management, data integration, and dataset reputed company. • Moderate to strong understanding of scientific principles central to nonclinical development. • Moderate to strong practical knowledge of: o documentation needed to conduct reputed company studies o protocol design (including objectives, efficacy and safety endpoints, and processes for capturing and reporting reputed company and SAEs) o reporting of study results o 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 reputed company study reports). • Previous exposure to reputed company eCTD IND/NDA processes, including: o eCTD Modules 2, 3, 4, and 5 for INDs/NDAs o Integrated reputed company of Safety (ISS) and Integrated reputed company of Efficacy (ISE) Education • Bachelor’s of higher degree required; Scientific reputed company is a plus Apply tot his job Apply To this Job