Contract Medical Writer (RA20-212)
We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late stage clinical development. We expect you to bring an innovative mindset, scientific curiosity, a lot of energy and pragmatism.
The Contract Medical Writer is responsible for managing all aspects of the writing and editing of clinical, regulatory, and scientific documents for publication and submission to regulatory agencies (US and ex-US).
ABOUT CATALYST BIOSCIENCES
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet needs within bleeding and complement related disorders. Catalyst has compounds that span the value chain from the earliest discovery to late stage clinical trials with the intent of commercialization.
- Write, edit, prepare and coordinate the production of a broad scope of documents (eg, investigator’s brochure, clinical study protocols, clinical study reports (CSRs), and other regulatory and clinical trial documentation as necessary
- Serve as primary writer for abstracts, posters, presentations, and manuscripts for submission to scientific conferences and peer-reviewed journals
- Serve as a key cross-functional point of contact for clinical, preclinical, CMC, regulatory, and scientific staff to synthesize analytical and proprietary information into holistic and coherent narrative documents
- Compile, analyze, and summarize data from statistical tables and other sources as needed
- Aid in the preparation and maintenance of corporate document standards, styles, and formats to create professional and cohesive documents (i.e., margin widths, font style and size, header style and size, headings and subheadings, table and figure formats and styles, templates, and best practices)
- Prepare graphic presentations using graphic software applications
- Manage various projects simultaneously and maintain timelines for document completion (from conception to final signature)
- Primary company interface with eCTD preparation and submission vendor
- Advanced degree in a scientific discipline, or in English or journalism (with additional science coursework), or equivalent, and 5+ years experience as a medical writer at a leading biotech/pharmaceutical company or as a consultant
- Experience in preparation of clinical/regulatory documents for US and non-US regulatory submissions required (eg, clinical protocols, INDs, NDAs, BLAs, CTDs)
- Excellent written communication
- Highly detail-oriented and self-motivated, with excellent follow-through
- Experience in preparation of preclinical/CMC documents is a desired plus
- Strong analytical and business communication skills
- Experience in eCTD preparation & submission a plus
- Proven experience in using negotiating, influencing, and problem-solving skills in order to meet document timelines
- Experience using Microsoft Word, Excel, PowerPoint, Visio, Prism, EndNote, Adobe Illustrator, and Adobe Photoshop required
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to email@example.com, referencing requisition number (RA20-212) in the subject line.