Taiho Oncology in is hiring: Associate Director, Medical Writing in Princeton

Associate Director, Medical Writing (Healthcare)

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. 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. 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. 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 all 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 conjunction with Regulatory Affairs and with internal standard operating procedures in a timely and accurate manner.
• Understand publishing standards for FDA and MAA.
• Oversee and review medical writing deliverables assigned to contractors 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.
• Prepare project and/or status reports.
• Proficient in Microsoft applications and document management systems.

Education/Certification Requirements:

• Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.

Knowledge, Skills, and Abilities:

• 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 involve 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.
• The incumbent in this position may be required to perform other duties, as assigned.

The pay range for this position at commencement of employment is expected to be between $187,000 – $220,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.