About This Role:

As the Sr 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 will 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 complex clinical documents for regulatory submissions on one or more programs
• Lead strategy-related discussions related to document development
• Identify area of process improvement within and outside the department and lead the discussions to implement change
• 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.

Required Skills:

• 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

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.