- Supports the clinical development team to develop high-quality, scientifically accurate medical communications materials including, but not limited to: protocols, ICFs, Investigator Brochures, clinical study reports, abstracts, posters, presentations, White Papers and manuscripts.
- Organizes the team meetings for document review; leads the adjudication of comments and edits; prepares pre-meeting agenda, key points for discussion, and meeting minutes.
- Partners with data managers and biostatisticians to engage early in the planning of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents.
- Works closely with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to ensure that results descriptions and messages in clinical documents accurately reflect the data in TFLs and statistical analyses.
- Builds timelines for deliverables with the study teams and adheres to agreed timelines.
- Follows SOPs and regulatory compliance; contributes to SOP development and standardization of templates and related processes, and internal best practices and processes for critical document development.
- Follows International Conference on Harmonization (ICH) and other applicable regulatory guidelines.
- Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements.
- Degree in life-sciences or medical-related studies; graduate degree preferred (Master’s or PhD).
- Five years of relevant medical writing experience in the pharmaceutical industry; experience in oncology related medical writing preferred.
- Experienced in medical writing responsibilities associated with various development stages. Excellent writing ability with strong editorial and formatting skills.
- Experience writing clinical study reports, protocols, ICFs, investigator’s brochures, safety reports, publications, abstracts.
- Experience in interacting with cross functional study teams; understands when to escalate problems.
- Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH. Guidelines regarding drug development, clinical research and medical writing standards.
- Ability to work independently and work effectively under pressure.
- Attentive to details.
- Mastery of English language; excellent verbal and written communication skills.
- Demonstrated ability to prioritize tasks, advance multiple projects simultaneously, and deliver high-quality documents according to timelines.
Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.
Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.