Remote Scientific / Technical Writer wanted | $100-$150 per hour
Added 2020-12-17 19:49:42 +0000 UTCCOMPANY/PUBLICATION: DALYA PARTNERS
CMC scientific/technical writer needed to support BLA.
Duration: six (6) months
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Assist in the organization and preparation of technical data, development reports, process descriptions, qualification reports, CPV reports and annual product reviews, and QRM risk assessments.
- Create and implement tools and templates for document preparation.
- Facilitate editing and formatting of documents and coordinate document review and approval.
- Organize and tabulate experimental data and link to reports.
- General administrative assistance, as requested.
DEMONSTRABLE EXPERIENCE:
- BS/MS/PhD in scientific discipline such as chemistry, biochemistry, chemical or biochemical engineering AND 2+ years in biotechnology/pharmaceutical industry.
- Preparation of technical documents (Development Reports, Research Proposals and CMC Sections of Regulatory Documents).
- Preparation of GMP documentation such as SOPs, Qualification Reports, CPV reports and annual product reviews, process descriptions, and QRM risk assessments.
- Excellent writing and document skills are essential together with strong graphics, editing, formatting and organization skills.
- Familiarity with ICH and FDA guidelines, GMP and quality compliance requirements.
- Expertise in product and vaccine development in the areas of analytical or process development of formulation are a plus.
Keywords: process development; report; recombinant; nanoparticle; vaccine; global; public health; regulatory; BLA; ICH; FDA; CMC; eCTD; drug substance; 3.2.S.2.6; 3.2.S.4.4JOB SUMMARY:
- Looking for: Technical Writer
- Location: Remote
- Compensation: $100-$150 an hour
CONTACT INFORMATION:
Original job posting: Click here
Website: http://www.dalyapartners.com
