Principal Medical Writer - Biogen, Cambridge, MA
- Cambridge, MA
- Department: Regulatory
- Region: US
The Principal Medical Writer will be responsible for providing medical writing for clinical and regulatory documentation required for the conduct and submission of results of clinical trials. This position interacts with other medical writers, document managers, document quality reviewers, and cross-functional teams (e.g., SMT, CDT, process improvement committees), in order to create/author/manage documentation required to support clinical trials and regulatory submissions. Leads cross-functional team and drives decision making. Leads strategy-related discussions related to document development. Identifies areas for process improvements within and without department and leads discussions to implement change. In addition they will also:
-Independently prepare complex clinical documents; independently coordinate 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
Excellent written and oral communication skills. Excellent organizational and meeting skills. Strong understanding of therapeutic area(s). Ability to analyze data and make recommendations for consistent data reporting standards. Strong understanding of standard clinical document types. Strong understanding of internal and external guidelines related to document preparation.
Education: Master’s required PhD preferred Life or Health Science discipline
7+ yrs regulatory writing experience with Master’s 6+ yrs regulatory writing experience with PhD
All your information will be kept confidential according to EEO guidelines.
Contact Person: Vera Buris, Senior Manager, Global Safety and Regulatory Sciences (GSRS)
Assignment Date: 02/10/2021
Location: 300 Binney Street, 93C27, Cambridge, MA 02142