Scientific Writer / Technical Writer job in Gaithersburg, USA

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Job type: Permanent

Discipline: Medical Communications, Medical Writing, Media & Publishing

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities:

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 g.watson@proclinical.com.

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.

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