Associate Principal Medical Writer - (Cambridge, MA)

Position summary The main purpose of this position is to provide 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., study management teams, clinical development teams , process improvement committees), in order to create/author/manage documentation required to support clinical trials and regulatory submissions. The Medical Writer participates on cross-functional teams and influences decision making. They will also lead strategy discussions related to document development and may make recommendations for process improvements within department and participates in discussions to implement change. 1. Independently prepares moderately complex clinical documents for 1 or more programs; coordinates preparation of clinical documents by other writers with minimal supervision 2.