Poseida Therapeutics, Inc. is seeking a talented Medical Writer to join our team in San Diego, CA.
- Create and edit documents associated with clinical research in oncology and/or gene therapy study protocols, study reports (esp. CSRs), annual reports, investigator brochures, INDs, BLAs, NDAs, SOPs, abstracts, posters and manuscripts.
- Manage medical writing projects by coordinating and facilitating document reviews with the clinical study team and ensuring writing projects are completed within specified timelines.
- Ensure document content and style adheres to appropriate regulatory guidelines and complies with relevant or client style guidelines.
- Review and provide support for QC of complex documents determining appropriateness of content/format for clinical writing.
- Bachelors, Masters, or PhD in a scientific or medical field or equivalent required.
- At least 3 years medical writing experience in a contract research organization or pharmaceutical or biotechnology firm.
- Should have experience in many of the above activities.
- Demonstrated understanding of the drug/medical device development process and a broad knowledge of requirements for FDA/Regulatory Agency submissions.
- Working knowledge of ICH E3, E6, M4 guidelines, integrated summaries of safety and efficacy; extensive clinical/scientific writing skills, understanding of statistics, strong competency in MS Office and Adobe applications.
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
- Must be computer literate and proficient in Microsoft Word, Excel, Endnote, and PowerPoint.
- Excellent interpersonal skills and team leadership skills.
- Ability to work on several projects at once while balancing multiple and overlapping timelines.
Poseida Therapeutics is a clinical-stage biotechnology company translating best-in-class gene engineering technologies into lifesaving treatments for patients with high unmet medical need. The company is developing a wholly-owned pipeline of autologous and allogeneic CAR-T product candidates, initially focused on the treatment of hematological malignancies and solid tumors, as well as gene therapies for orphan genetic diseases. Poseida has assembled a suite of industry-leading gene editing technologies, including the piggyBac® DNA Modification System, Cas-CLOVER™ and TAL-CLOVER™ site-specific nucleases and Footprint-Free® Gene Editing. For more information, visit www.poseida.com