Associate Director, Medical Writing

Taiho Oncology, Inc. • Princeton, NJ

2d • $194,650 - $229,000 • Remote

About The Position

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.

Requirements

• Bachelor’s Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.
• Minimum of 8 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
• Extensive previous experience in Medical Writing in clinical drug development, preferably some experience in oncology.
• Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
• Knowledge of template development, document management systems and requirements
• Experience developing and implementing medical writing processes for all stages of clinical development.
• Strong working knowledge of medical writing requirements and document components.
• Good interpersonal skills that involves working well in a team environment and the ability to lead others.
• Good organizational and planning skills; drive for results.
• Ability to read, analyze and interpret scientific and technical information.
• Effective analytical/problem solving skills.

Responsibilities

• 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 conjunction with Regulatory Affairs and with internal standard operating procedures in a timely and accurate manner.
• Understand publishing standards for FDA and MAA.
• Manages and oversees medical writing deliverables assigned to internal and contract writers or other third party vendors.
• Represent Global Medical Writing department on clinical development cross-functional teams and project initiatives.
• Develop and implement medical writing processes in line with SOPs.
• Prepares project and/or status reports.
• Proficient in Microsoft applications and document management systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees