Job Summary

• This role leads the development of regulatory documents including CTD modules and briefing documents for Biogen programs from early development to approval.
• The successful candidate must possess strong leadership skills to manage external vendors and support nonclinical writers in preparing complex regulatory submissions.
• Biogen offers a mid-sized environment fostering individual impact while providing the stability and resources of a well-established business committed to life-changing medicines.

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Skills & Requirements

Key Requirements

• Life Science degree required
• 5 years clinical medical writing experience
• 3 years nonclinical writing experience preferred
• Management level position

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