Contract Scientific Editor
A biopharmaceutical client based in Cambridge, Massachusetts is seeking to hire a Scientific Editor for a 6-month contract. This individual will be working on various non-clinical 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.
The Scientific Editor will be responsible for: 1) writing and editing 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. 2) Perform Quality Control review (data verification) for both Module 2 and Module 4 nonclinical documentation. 3) Develop, communicate, and ensure adherence to project timelines, internal and external style guides, and content-rich templates. 4) coordinate the nonclinical components (timeline, population, reviews, and revisions) on projects of narrow scope (e.g., annual regulatory updates). 5) 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.6) Review draft manuscripts.7) Assume lead scientific writing responsibility on projects if needed, utilizing both regulatory and publication documentation expertise.
Location: Cambridge, MA
Compensation: $60-70 per hour
Duration: 6-month contract
- 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
Sthree US is acting as an Employment Business in relation to this vacancy.