Scientific Writer / Technical Writer
Proclinical is currently recruiting for a Scientific Writer for a clinical-stage vaccine company located in Gaithersburg, MD. As the Scientific Writer, you will have responsibility for the writing and preparation of scientific documents including support for Analytical Development, Upstream/Downstream Process Development, Formulation and Tech Transfer.
- Write first draft of technical reports, regulatory submissions, CMC sections etc. after reviewing and analyzing technical data with subject matter experts
- Assist team and subject matter experts in the organization and preparation of technical data and documents for assay development, process development and optimization, and validation.
- Write SOPs. Compile/analyze data and prepare data presentations.
- Act as team expert for document handling, template preparation; facilitate editing and formatting of documents and coordinate document review and approval.
- Organize and tabulate experimental data and link to reports.
- Route documents for approval.
- Participate in team meetings to provide input regarding deliverables, timelines, and processes needed. Update progress weekly.
- Work independently with minimal supervision.
- General administrative assistance, as requested.
Skills and Requirements:
- BS/MS/PhD in scientific discipline such as chemistry/biochemistry, chemical or biochemical engineering
- 3-5+ years biopharmaceutical experience with expertise in analytical, process development, Tech Transfer or formulation.
- Experience in infectious disease and especially vaccine development would be preferred.
- Knowledge of recombinant baculovirus expression systems would be preferred
- Excellent writing skills are essential together with strong formatting, editing, and organization skills.
- Experience in CTD preparation; includes variety of technical documents such as SOPs, Qualification Reports, Development Reports, Research Proposals, protocols, and CMC Sections of Regulatory Documents
- Familiarity with ICH and FDA guidelines, GMP and quality compliance requirements preferred.
- Good computer skills and kowledgeable with scientific and document preparation software: Word, Excel, PowerPoint, Graphpad Prism, Endnote or similar reference software
If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929-223-4835 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.