Associate Principal Medical Writer

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 (e.g., SMT, CDT, process improvement committees), in order to create/author/manage documentation required to support clinical trials and regulatory submissions for preclinical and early phase clinical programs (pre-IND briefing materials, IND/CTAs). You will participate in cross-functional teams and influences decision making. You may lead strategy discussions related to document development and make recommendations for process improvements within department and participates in discussions to implement change.

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; advanced degree in Life Sciences or health discipline preferred)
• 5 years in the biopharmaceutical industry with 3 years medical writing experience (Advanced degree, academic research, and/or transferrable skills may be considered in lieu of industry experience)
• Ability to interpret data, including nonclinical data; Neuroscience experience preferred
• Solid understanding of standard clinical documentation
• Solid understanding of internal and external guidelines related to document preparation

#LTD-1

Additional Information

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.