Medical Writer

  • Location: Silicon Valley
  • Type: Contract To Hire
  • Job #32662

Innovative Biotech Start-up in Silicon Valley, CA is seeking a Medical Writer to join their growing team!

The Medical Writer will be responsible for creating clinical/regulatory documents that are publication ready (e.g., IND/NDA/BLA in Microsoft Word). This position will be the lead medical writer on programs varying in stages of development.

Essential Functions & Responsibilities

  • Write clinical and CMC sections of MAA/BLA using Microsoft Word templates and styles for publication ready dossier
  • Develop and maintain timelines for document creation, revision, and completion in collaboration with cross-functional study team members (Product Development, Quality, & Regulatory Affairs)
  • Assist in the development and maintenance of writing tools, such as templates and style manuals
  • Provide training on medical writing templates, quality control (QC) and quality assurance (QA) procedures, SOPs, and processes within the department and across departments
  • Contribute to the development of electronic document systems and tools
  • Provide project teams with guidance and problem resolution related to document generation
  • Ensure writing meets scientific and Regulatory standards and meets objectives
  • Drive document writing and review process
  • Coordinate and manage review cycles to triage, incorporate, and resolve team comments, and lead discussions on document revision and finalization
  • Manage outsourced publishing and submission operations
  • Collaborate with external publishing vendors, as well as internal SMEs.
  • Provide quality control support to other document authors (review of various regulatory documents)
  • Incorporate comments and QC/QA findings and resolve queries to present a ‘finished’ final document/submission
  • Take on other duties as assigned

Education, Experience, Knowledge

  • Advanced life sciences degree preferred, eg, MS, RN, RPh, PhD. A Bachelor’s degree required. A minimum of 5 years regulatory medical writing experience in the biotech/pharmaceutical industry. An equivalent combination of experience and education may be considered.
  • Experience producing INDs/BLAs/NDAs/MAAs, and familiarity with eCTD structure and granularity requirements
  • Experience with clinical protocols and clinical study reports including assembly of all CSR ICH appendices
  • Experience with electronic document control and management system
  • Familiarity with statistical analysis
  • Working knowledge of good publication practice and regulations relevant to medical writing
  • Working knowledge of GCP, GLP, GMP, and ICH guidelines and related FDA/EMA guidance on submission elements and integrated summaries of safety and efficacy

Technical Knowledge Required

Software Knowledge: Windows, MS Office (Outlook, Excel, PowerPoint, Teams) and expert MS Word skills, Adobe Acrobat, EndNote or other citation software, electronic document management systems use  

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

We are uploading your application. It may take a few moments to read your resume. Please wait!