Pleasanton, CA, USA ● Princeton, NJ, USA ● Virtual Req #393
Tuesday, October 1, 2024
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. 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 empower us to innovate and touch the lives of more and more patients. We invite you to join us.
Remote
Employee Value Proposition:
As a Senior Manager, 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. 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.
Position Summary:
The Senior 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, and Health Authority responses.
- Collaborate with Global Development Teams and Clinical Development to ensure alignment with program objectives.
- Oversee and review medical writing deliverables assigned to contractors or other third party vendors.
- Participate in Global Medical Writing initiatives on clinical development cross-functional teams.
- Assist with development and implementation of Medical Writing process improvements 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. Advanced degree preferred.
Knowledge, Skills, and Abilities:
- Minimum of 5 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 in oncology.
- Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
- Knowledge of template development, document management systems and requirements.
- Excellent writing skills.
- 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.
- Strong PC skills including Medical Writing software, Windows, and MS Office products specifically Word, Excel, MS Project, and PowerPoint.
The pay range for this position at commencement of employment is expected to be between $161,500 and $190,000 annually. 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. 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.
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.
The incumbent in this position may be required to perform other duties, as assigned.
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