Manager Medical Writing
New York, NY
Provide management and oversight of contracted staff in the preparation of primarily clinical-regulatory documents for submission to the United States Food and Drug Administration and other regulatory authorities worldwide in support of investigational new drug and marketing authorization applications.
This includes phase 1 to 4 protocols and clinical study reports, integrated data summaries (eCTD Module 2 and 5), annual reports, investigator’s brochures, briefing documents, and others.
Serve as the functional representative on multiple project teams.
Author and edit clinical-regulatory documents and review such documents according to internal procedures and requirements.
Provide back up support. Must be experienced in performing and overseeing quality control review of clinical-regulatory documents.
Must be able to work in a team environment, be flexible to changing priorities, and multi-task across multiple projects.
Manages the development of high-quality, multidisciplinary documents within corporate timelines for submission to regulatory agencies worldwide.
Manages outsourced medical writing projects, primarily clinical submission documents for the FDA and other regulatory authorities worldwide. This includes but is not limited to:
Review of deliverables against quality and in-house standards.
Coordination of development activities with Otsuka Operations Team members.
Issue resolution. - Quality control of non-published and published deliverables.
Vendor assessment and day-to-day vendor oversight. -
Training of external vendors on Otsuka's SOPs and business processes.
Budgeting and contract management. -
Dispute resolution with vendors.
Authors and/or edits key regulatory documents as needed, including but not limited to clinical study reports, Investigator's brochures, annual reports, briefing packages, and integrated data reports. -
Represents Medical Writing on project teams, including but not limited to attendance at team meetings, communication of project status and critical path issues, and provision of dates to project management team for input into the clinical trial management system (IMPACT).
Provides relevant and timely project information to the functional area head, ensuring that adequate coverage of medical writing needs is maintained in accordance with the company's goals and objectives.
Adheres to and helps maintain departmental SOPs and working practices, including the necessary model documents and style guidelines, for standardized processes and style expectations across projects.
Provides backup support to other Medical Writing Managers.
Knowledge, Skills and Education: Knowledge:
Solid knowledge of the clinical development process, good clinical practices, and the medical writing process.
Solid understanding of the requirements of regulatory writing, including ICH guidelines.
Skills: -Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat.
Strong communication skills. -Knowledge of how/when to apply organizational policy and/or procedures to a variety of situations.
Education: BS degree or higher in a scientific field with 6 years of experience in pharmaceutical medical writing.
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Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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