Manager Medical Writing
Posted on: November 22, 2021
- 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
- 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
- Serve as the functional representative on multiple project
- 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.Job Responsibilities:
- 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
- Coordination of development activities with Otsuka Operations
- Issue resolution. - Quality control of non-published and
- Vendor assessment and day-to-day vendor oversight. -
- Timeline management.
- Training of external vendors on Otsuka's SOPs and business
- 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
- 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
- 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
- Adheres to and helps maintain departmental SOPs and working
practices, including the necessary model documents and style
guidelines, for standardized processes and style expectations
- 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
- Education: BS degree or higher in a scientific field with 6
years of experience in pharmaceutical medical writing. Come
discover more about Otsuka and our benefit offerings; . 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.
Statement Regarding Job Recruiting Fraud Scams Job postings, job
offers, or introductions to enter into a business relationship with
Otsuka through a third-party vendor may be unauthorized. Avoid
being the subject of a scam by dealing only directly with Otsuka
through its official Otsuka Career website . Any authorized
third-party vendor job boards should redirect any inquiry to this
Otsuka Career website.
Keywords: Otsuka, Philadelphia , Manager Medical Writing, Healthcare , Philadelphia, Pennsylvania
Didn't find what you're looking for? Search again!