Sr. 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, we are driven by our mission to improve the lives of cancer patients.
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.
We believe in empowering our employees through continuous learning, career development, and a supportive culture that values diverse perspectives and encourages innovation.
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.
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 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, 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.
* Oversees and review...
- Rate: Not Specified
- Location: Princeton, US-NJ
- Type: Permanent
- Industry: Arts
- Recruiter: Taiho Oncology
- Contact: Not Specified
- Email: to view click here
- Reference: DF416
- Posted: 2024-12-05 07:28:55 -
- View all Jobs from Taiho Oncology
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