Sr. Manager, Medical Writing at Taiho Oncology in Princeton, New Jersey

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, 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 reviews medical writing deliverables assigned to contractors or other third party vendors.


• 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.  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 some experience 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 involves 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 read, analyze, and interpret scientific and technical journals and legal documents.


• Ability to respond to inquiries or complaints from regulatory agencies.


• Ability to write procedures.


• Ability to effectively present information to internal and external clients.


• Ability to understand mathematical concepts such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.


• Ability to define problems, collect data, establish facts, and draw valid conclusions.


• Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.


• Strong PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized at Taiho).

The pay range for this position at commencement of employment is expected to be between $161,500 and $190,000 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 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. 

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