Work directly with scientists within Early Development and Research and Clinical/ Regulatory Operations and Regulatory Affairs departments on various nonclinical regulatory documents (e.g. Investigator Brochures, Nonclinical Study Reports, Annual Reports, CTAs, INDs, and NDAs, specialized Regulatory documents) as well as nonclinical publications and study reports. This position can assume lead scientific writing responsibility on these projects if needed, utilizing both regulatory and publication documentation expertise. This position can also lead writing assignments on other programs in early development.Writes nonclinical study report drafts from templates, nonclinical portions of investigators brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with the scientists and project team with minimal supervision.
Perform Quality Control review (data verification) for both Module 2 and Module 4 nonclinical documentation
Write, edit nonclinical study protocols, reports, and summary document sections checking for grammar, consistency, style, and clarity
Create and maintain functional area content-rich templates
Develop, communicate, and ensure adherence to project timelines, internal and external style guides, and content-rich templates
Create / QC nonclinical written and tabulated summaries
Coordinate the nonclinical components (timeline, population, reviews, revisions) on projects of narrow scope (eg, annual regulatory updates)
Represent the nonclinical function on cross-functional submission working group meetings
Develop, communicate, and ensure adherence to project timelines
Independently assess gaps and identify inconsistencies within and across documentation and submissions, based on internal style guides and regulatory agency requirements. Independently propose solutions to address gaps and inconsistencies.
Review draft manuscripts
BS/BA or higher with 4+ years pharmaceutical or related experience
Experience with drug development, scientific editing/writing or publications preferred
Ability to work independently to resolve issues and inform manager of resolution
Excellent oral and written communication skills, including presentation and facilitation skills
Ability to meet strict deadlines and multitask in a fast-paced team environment
Proficiency in MS Office; experience using electronic document management systems
Associated topics: article, composer, compositor, content, editorial, newswriter, proofread, screenwriter, web, writer
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.