Job description

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, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to experience multiple facets of medical writing in a dynamic, collaborative and cross functional environment.
Position Summary:
The Manager, Medical Writing is accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, health authority briefing books and clinical summary documents for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval.
Performance Objectives:

• Responsible for the development of high-quality clinical 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.
• Collaborate with Global Development Teams and Clinical Development to ensure alignment with program objectives.
• Participate in Global Medical Writing initiatives on clinical development cross-functional teams.
• Assist with development and implementation of Medical Writing processes improvement in line with SOPs.
• Own and update assigned Medical Writing SOPs, as necessary.

Education/Certification Requirements:

• Bachelor’s Degree in life science, health-related or pharmaceutical field, or the equivalent in experience.

Knowledge, Skills, and Abilities:

• Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
• Knowledge of template development, document management systems and requirements.
• Fluency in English, both written and verbal.
• Ability to work with mathematical concepts
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Advanced use of Microsoft Office Tools including Word, PowerPoint, Excel, and Teams.
• While performing the duties of this job, the employee is frequently required to sit, talk and hear.
• The employee is occasionally required to walk.
• The noise level in the work environment is usually quiet.

The pay range for this position at commencement of employment is expected to be between $131k - $155k 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. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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.
#Location-United States #LI-Remote

Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
COVID-19: All new employees of Taiho Oncology are required to be fully vaccinated against COVID-19. Employees may request an exemption from this mandatory vaccination policy if the vaccine is medically contraindicated for them or medical necessity requires a delay in vaccination. Employees also may be legally entitled to a reasonable accommodation or exemption under applicable law if they cannot be vaccinated because of a disability, or if the provisions in this policy for vaccination conflict with a sincerely held religious belief, practice, or observance, or for other reasons protected by applicable law.
Requests for exemptions and reasonable accommodations must be initiated by notifying People@taihooncology.com that you will be requesting an exemption. All such requests will be handled in accordance with applicable laws and regulations.
The incumbent in this position may be required to perform other duties, as assigned.

Job Type: Full-time

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