Company Profile

Rakuten Aspyrian, Inc., is a privately funded clinical stage biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform.

Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses.

Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study for ASP-1929 to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy of ASP-1929 in patients with other cancer types.

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 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.