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CMC Submissions and Technical Writing Manager

Seattle Genetics, Inc.

Bothell, WA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
High school or equivalent
Areas of Expertise Desired:

Job Description

Major Duties and Responsibilities:

•   Possesses the ability to write in a clear and concise manner and edit technical information in support of high-quality regulatory submissions
•   Able to work efficiently to facilitate the on-time delivery of regulatory documents
•   Possesses strong proficiency in CMC technical writing and writing-based software systems (e.g. Word, Visio, Adobe)
•   Has strong knowledge of regulatory requirements for development (IND, IMPD, etc) and commercial (BLA, MAA, etc) stage programs
•   Manage submissions to regulatory bodies from CMC level
•   Manage the efforts of junior team members
•   Develop strategic content and manage submission workflows and timelines
•   Edit technical information in support of high –quality regulatory submissions.
•   Develop, implement, and lead training exercises on writing/reviewing systems, cCTD views and defined work flows
•   Establish and maintain systems and structures that support life-cycle management for a broad range of programs at different stages of development
•   Build relationships to effectively interact in cross-functional teams of technical experts; interfacing with adjacent departments according to defined roles and responsibilities.


Requirements (technical skills, key characteristics, education, etc.):

•   BS/BA in a natural or physical science discipline
•   5-7 years of experience in CMC technical writing and/or regulatory affairs
•   Proven ability to define and execute complex workflows in order to deliver submission ready document sets on time and with high quality
•   Possesses the ability to interact effectively in cross-functional teams of technical experts; interfaces with adjacent departments according to defined roles and responsibilities
•   Proficiency in the regulatory requirements for the rest of world (ROW); base knowledge in the NDS requirements for Health Canada a plus
•   Strong knowledge of regulatory systems, eCTD structures, and writing styles as it applies to the m3 Quality module
•   Possess core proficiency and knowledge in EDMS-based structures and workflows

Seattle Genetics is an equal opportunity employer.  All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status

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