Summary of the Position
Catalyst Biosciences is seeking an experienced Medical Writer in their South San Francisco office. This position will assist in preparing complex clinical study documents (clinical study protocols/amendments, clinical study reports, investigator’s brochure). This Medical Writer will report directly to the Senior Director, Clinical Operations and will have the opportunity to collaborate cross-functionally and ensure key messages are consistently aligned in the preparation of clinical regulatory documents. Our Medical Writer assumes responsibility for understanding our scientific and clinical aspects in depth and serve as a key resource for both internal teams and clients.
- Work with project teams to draft, edit, format, and finalize documents including, but not limited to: clinical protocols and amendments, investigator’s brochures, regulatory documents, and clinical study reports according to company guidelines in order to support drug development
- Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program.
- Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
- Provide quality control review of clinical and regulatory documents including data output.
- Contribute scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and to cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.
- Responsible for assembling all summary submission documents (e.g., Pivotal Study Reports, Regulatory Documents, Clinical Summary of Efficacy, Clinical Summary of Safety, and Clinical Overview) into one dossier and submit to the appropriate agencies.
- Coordinates beginning-to-end clinical study protocol development activities which includes gathering cross-functional input, hosting meetings to formulate the investigational plan, preparing synopses for use in FDA pre-submissions, developing the study concept into full clinical study protocols, incorporating review comments and finalizing the complete clinical study protocol
- Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
- Strong written and verbal communication skills, with the ability to clearly present clinical data.
- Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills
- Keeps abreast with current industry practices and regulatory requirements and guidelines pertaining to medical writing.
- Good understanding of clinical experimental methods, clinical study design, regulatory submissions, and statistical analysis
- A minimum of 3-5 years medical writing experience in a pharma, biotech, or a combination of CRO and pharma setting with in-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
Please send CVs/resumes directly to Human Resources, email@example.com referencing job number FD18-188 in the subject line.