Manager, 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, 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.
• Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
• Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
• Owns and updates 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:

• Minimum of 4 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
• Previous experience in Medical Writing in clinical drug development, preferably some experience in oncology.
• Working knowledge of Medical Writing requirements and document components.
• Experience with templates and template development, and document management systems.
• Excellent writing skills.
• 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.
• Ability to write procedures.
• Ability to follow instructions and synthesize information from multiple sources.
• Strong PC skills including intermediate/advanced proficiency with MS Word, and basic proficiency with other MS Office products. Adept in learning additional software utilized at Taiho.

The pay range for this position at commencement of employment is expected to be between $141,950 - $167,000 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 annual bonus/incentive comp plans, potential long term incentive plan, 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 a candidate/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.

#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 [email protected] . 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.

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