Sr. Medical Writer
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.
- Drives medical writing activities and review processes for all regulatory filings and clinical study documents in compliance with applicable FDA and other agencies and ICH/GCP guidelines.
- Participates in the strategic publication planning process and implementation of publication plans, including working with author groups to develop and author manuscripts, abstracts, and presentations for scientific congresses.
- 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.
- Routinely engages clinical research and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiences
- 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.
- Leads and/or participate in development of medical writing processes and infrastructure development Develops and implements templates, style standards, and standard operating procedures to ensure consistent and high-quality deliverables.
- MS or PhD in a scientific or medical discipline with a minimum of 8 years of medical writing experience in the pharmaceutical industry or CRO environment with 5 years direct medical writing experience.
- 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 have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment and be accurate with a high attention to details.
- Expertise in the advanced features of Microsoft Word, Excel, and PowerPoint 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 is preferred.
- Bi-lingual English and Chinese is required. Proficiency in translating biotechnology, biological sciences and biomedical documentation at industry level.