About This Role

As the AD of Safety & Regulatory Alliance Manager, you will lead diverse internal and external global stakeholders to execute safety data exchange agreements (SDEAs) with Biogen’s corporate partners.  SDEAs are critical documents to clarify safety commitment accountability, ensure compliance with global regulations and corporate agreements, and to support the growth and maintenance of Biogen’s pipeline.  You report to the Head of Safety and Regulatory Alliance Management within the Quality, Operations, Labeling, and Medical Writing function of the Global Safety and Regulatory Sciences department within Research and Development.  You work directly with many types and sizes of corporate partners across product development and postmarketing stages.

 What You’ll Do

·       Stakeholder outreach and corporate agreement review to identify and support fulfillment of SDEA obligations

·       Lead, author, revise and execute on time SDEAs with subject matter experts and corporate partners

·       Act as a subject matter expert for safety document authoring strategy and contents in audits and inspections

·       Manage and enhance processes for execution and transparency

Who You Are

You are flexible and enjoy working in a dynamic area of detailed and accurate individual work balanced with collaborative teamwork.  You have excellent judgement, analytical, and communication skills, and enjoy multi-tasking, process management, wide networks, solving challenges, and influencing and engaging others for optimal outcomes.

Required Skills

·       B.S. in life sciences and > 5 years of experience in pharmacovigilance

·       Microsoft word proficiency

·       Independent project leadership

·       Attention to detail

·       Ability to listen, analyze data, and successfully communicate verbal and written solutions

Preferred Skills

·       Safety agreement or safety contracts experience

·       Alliance management experience

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.