Scientific Writer/ Editor
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The Scientific Editor will work directly with scientists within Early Development and Research 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.
Summary of Key Responsibilities
- Writes nonclinical study report drafts from templates, nonclinical portions of investigator’s 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
- Experience with drug development, scientific editing/writing or publications preferred
- BS/BA or higher
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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