
Principal - Medical Writing
Independently prepares complex clinical documents; independently coordinates preparation of clinical documents for regulatory submissions and/or publication strategies for one or more programs Represents department on clinical teams (e.g. SMT, CDT); leads document-related meetings; reviews statistical analysis plans and clinical data reports to ensure consistent data reporting within a program and/or therapeutic area. Mentors junior writers on departmental processes related to document preparation (e.g., planning document-related meetings, developing document timelines); reviews documents written by junior writers for content and format; coordinates work of multiple writers contributing to a regulatory submission or publication strategy. Leads departmental initiatives; represents department on interdepartmental initiatives.
7+ yrs regulatory writing experience
PhD is a plus
Strong understanding of internal and external guidelines related to document preparation.
Ability to analyze data and make recommendations for consistent data reporting standards. Strong understanding of standard clinical document types.
Documentation
Data Analysis
Time Management
Presentation skills
Communication
Multitasking
Process Improvement
Detail Oriented
Strategic planner
According to JobzMall, the average salary range for a Principal - Medical Writing in 225 Binney St, Cambridge, MA 02142, USA is $105,000 to $135,000 per year.
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Biogen, Inc. is a global biotechnology company, which focuses on discovering, developing, manufacturing and delivering therapies for neurological, autoimmune and hematologic disorders.

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