Associate Director, Medical Writing

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers.

Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission.

Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.

Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients.

Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy.

We invite you to join us.

Remote

Employee Value Proposition:

At Taiho Oncology, we are driven by our mission to improve the lives of cancer patients.

As an Associate Director, Medical Writing, you will work on various document types and play a critical role in transforming scientific data into compelling narratives that contribute to innovative cancer treatments.

Join a dedicated team that fosters a collaborative, patient-first environment, where your expertise and passion will directly impact patient care and advance oncology research.

We believe in empowering our employees through continuous learning, career development, and a supportive culture that values diverse perspectives and encourages innovation.

If you are ready to take on new challenges and make a meaningful difference, Taiho Oncology offers you the opportunity to grow, excel, and be a part of something bigger.

Together, we are relentless in our pursuit of better cancer treatments.  Join us in putting patients at the heart of everything we do.

 

Position Summary:

The incumbent is responsible for authoring Taiho Oncology, Inc., (TOI), documents submitted to Regulatory Authorities including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and relevant summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions for drugs in line with regulatory requirements and internal standard operating procedures.

 

Performance Objectives:


* Responsible for authoring TOI documents submitted to Regulatory Authorities (e.g.

FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions.


* Prepare documents in line with regulatory requirements in conjun...