Medical Writer

Company Profile

We are Rakuten Aspyrian Inc., a privately funded, clinical stage, Biotechnology Company headquartered in San Diego, California. We are focused on advancing innovative science into breakthrough products that provide cancer patients with new treatments to conquer their disease.

We are supported by investors that have the commitment to build a long-term company that integrates research, development and commercialization of cutting edge cancer therapies with the aim to transform cancer treatments. Our mission is “CONQUERING Cancer. For LIFE.”

We are developing therapies based on a novel proprietary technology platform that utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product will advance into Phase 3 pivotal clinical testing to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Given the rapid progression of the clinical studies we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

Position Summary

It is the Medical Writer’s role to manage various writing activities in coordination with the Clinical/Medical team. The Medical Writer will ensure consistency across documents, improve document quality and provide guidance on writing style. The Medical Writer will assist in the writing and review of publications, abstracts and clinical trial-related documents. The ideal candidate will have 7 + years of medical writing experience in a similar environment.

The Medical Writer will report to the Chief Medical Officer and work closely with the Clinical team.

Key Duties and Responsibilities

Manage medical writing activities by identifying contributors, reviewers and maintaining agreed upon timelines
Plan, write, edit, format, and finalize clinical program and trial-related documents, including but not limited to, IB, protocol/amendments, consent, clinical study reports, statistical analysis plans, along with Tables/Listings/Figures, regulatory submission documents including annual reports, and publications/abstracts/presentations)
Performs on-line clinical literature searches as needed
SOP and Guidance review and writing
Experience in developing style writing manuals or similar; familiarity with the AMA style guide
May also participate in R&D and other departmental writing/review activities as time allows
Work effectively across functional teams and represents medical writing
Other duties as assigned.

Desired Education, Skills, and Experience

Bachelor’s or Master’s degree in the science or writing discipline
Minimum 7 years related medical writing experience in biotech or similar environment
Demonstrates strong writing skills with sample work
Extensive knowledge of federal regulations, Good Clinical Practices, ICH-E3 and other guidance, as well as applicable US/International regulatory processes related to document preparation and production (including eCTD).
Broad knowledge of clinical development and statistics applications to the presentation of clinical data is a plus
Demonstrates strong organizational skills and ability to work well in a cross-functional team environment
Knowledgeable on documentation requirements for manuscript submissions to scientific and medical journals
Maintains familiarity with current industry practices, regulatory requirements, and guidance that affect medical writing
Strong ability to read, write and interpret the English language
Strong attention to detail
Strong proficiency in Word, Excel, PowerPoint, the use of templates, email and internet

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Aspyrian Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.