Senior Medical Regulatory Writer - 22-138
Fully Remote
Description

The Senior Medical Regulatory Writer will provide expert, hands-on medical writing and QC support for the programs and efforts of the Drug Development group. This role advises on, develops, and authors (and/or supervises external authoring) clinical and nonclinical documents for regulatory submission from pre-IND through NDA/MAA, as well as other documents for technical/scientific publications. This individual will build and maintain strong working relationships with the Clinical Development, Regulatory Affairs, Nonclinical, Global Safety, Biostatistics departments and external collaborators. This is a remote-based position.


Responsibilities: 

· Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials, and publications to medical journals

· Manage external medical writers as needed

· Complete writing assignments in a timely manner

· Maintain timelines and workflow of writing assignments

· Highly proficient with styles of writing for various regulatory documents

· Expert proficiency with client templates & style guides

· Mentor new medical writers and other members of the project team who are involved in the writing process

Requirements

· At least 3 years of previous experience in the pharmaceutical industry, focused in Oncology

· Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience

· The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline

· Substantial clinical study protocol + clinical study report experience, as lead author, required & understanding of clinical data

· Experience leading and managing teams while authoring regulatory documents with aggressive timelines

· Experience in regulatory submissions (clinical study reports) presented to regulatory authorities

· Experience being a project lead, or managing a project team

· Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus

· Experience with orphan drug designations and PSP/PIPs is a plus