SalaryUSD TBD TBD
The Senior Medical Writer will interact 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. Successful candidate will participate in cross-functional teams and influences decision making. They may lead strategy discussions related to document development and make recommendations for process improvements within department and participates in discussions to implement change.
· Independently prepares moderately complex clinical documents for one or more programs; coordinates preparation of clinical documents by other writers with minimal supervision
· Represents department on clinical teams (e.g., SMT, CDT); leads document-related meetings; reviews statistical analysis plans and clinical data reports as needed
· 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
· Participates on departmental initiatives
· Master’s required in a life science or health discipline. PhD preferred
· 1+ yrs. regulatory writing experience within a life science organization
· Ability to interpret data within a specific therapeutic area (neuroscience ideal)
· Solid understanding of standard clinical document types
· Solid understanding of internal and external guidelines related to document preparation
· Strong written and oral communication skills
· Strong organizational and meeting skills
All your information will be kept confidential according to EEO guidelines.
Senior Manager / Associate Director, Medical Health Outcomes Research