Job Description
ABOUT THIS ROLE:
As the Associate Principal Medical Writer, you will interact with other medical writers, document managers, document quality reviewers, and cross-functional teams, to create/author/manage documentation required to support clinical trials and regulatory submissions. You will participate in cross-functional teams and influence decision making. You may lead strategy discussions related to document development and make recommendations for process improvements within the department. You will also participate in discussions to implement changes.
WHAT YOU’LL DO:
· Independently prepare moderately complex clinical documents for one or more programs
· Coordinate preparation of clinical documents by other writers with minimal supervision
· Represent the department on clinical teams and lead document-related meetings
· Review statistical analysis plans and clinical data reports as needed
· Mentor 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
· Participate in departmental initiatives
WHO YOU ARE:
In addition to having exceptional written and communication skills, you successfully worked in a matrix environment where you collaborated with other clinical teams. You have strong regulatory writing experience and strong teamwork capabilities.
Qualifications
REQUIRED SKILLS:
· A Bachelor’s Degree in Life Sciences or health discipline required; Master’s degree preferred
· 4+ years regulatory writing experience within a life science organization
· Ability to interpret data within a specific therapeutic area; Neuroscience experience preferred
· Solid understanding of standard clinical documentation
· Solid understanding of internal and external guidelines related to document preparation
Additional Information
All your information will be kept confidential according to EEO guidelines.
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