Poseida Therapeutics, Inc. is seeking a talented Medical Writer to join our team in San Diego, CA.
These may include but are not limited to:
- 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.
Requirements, Knowledge, Skills and Abilities
- 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.
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to email@example.com.