Manager, Medical Writing
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, 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.
Requirements
- Bachelor’s Degree in life science, health-related or pharmaceutical field, or the equivalent in experience.
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
251-500 employees
