Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
Essential Duties and Responsibilities
- Drives medical writing activities and review processes for all regulatory filings and clinical study documents in compliance with applicable FDA and ICH/GCP guidelines.
- Remains informed on the latest professional, technological, and regulatory developments in medical writing and in relevant therapeutic areas.
- Establish standards for medical writing (e.g. writing guidelines, templates and QC, etc.), working practices, and SOPs.
- Serves as principal medical writer to prepare core clinical trial documentation (e.g., study protocols, investigator brochures, informed consent documents, case report forms, statistical analysis plans, monitoring plans, data management plans, etc.) and Regulatory documents (e.g., IND, NDA or BLA) to support drug development under strict timelines.
- Provides expertise on medical writing strategy and illustration of clinical data for completion of high quality clinical documents across departments or external CROs.
- Closely Works and interacts with principal statistician or CRO statistical groups, including participation in development of statistical analysis plans and design of statistical outputs.
- Coordinates and develops responses to health authority safety queries.
- Provides senior level review of various documents prepared by other writers (internal or CRO) as required. Ensures that all activities are conducted in adherence with relevant regulatory requirements.
- Coordinates review cycles, incorporates team comments, and leads document development meetings and other meetings on document revision and finalization.
Education and Experience
- MS or PhD in a scientific or medical discipline with a minimum of 10 years of medical writing experience in the pharmaceutical industry or CRO environment.
- Thorough understanding of FDA and ICH/GCP guidelines associated with nonclinical / clinical sections of INDs and NDAs.
- Demonstrated writing capability for clinical documents (e.g., clinical study protocols and clinical study reports, Investigator’s Brochures).
- Thorough understanding of drug development process in all phases, including clinical study conduct, data collection and analysis, and interactions essential for the production of regulatory submissions.
- Excellent oral, written, and presentation skills, an ability to lead discussions and resolve issues related to document development.
- Must be accurate and have high attention to detail and ability to generate clean, consistent, coherent documents.
- Expertise in the advanced features of Microsoft Word and ability to work effectively with a document management system.
- Demonstrated leadership skills in a cross-functional environment and problem-solving ability, with a sense of urgency.
- Demonstrated experience with producing INDs, BLAs, and NDAs in oncology area.