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.

Sr. Manager, Medical Information Quality is the Global Medical Information (GMI) process owner and lead for quality, compliance, and continuous improvement initiatives.  Supports strategy development and execution, to ensure the vision of GMI is enabled by a strong process, collaboration, and innovation.  Drives to ensure functional excellence, business process, and technology are optimized to enable the functional strategy.

This position is a US-based, remote position.

What You’ll Do:

GMI Process Owner

· Lead strategy and development of concise and compliant GMI processes and process documentation

· Lead GMI Process representative for R&D QMS activities

· Collaborate with GMI systems lead to ensure technology supports the GMI process

· Support development of training

· Lead in the development and oversight of GMI Process KPIs and threshold monitoring

Lead GMI Quality Program

· Lead development initiation and oversight of GMI Quality Program

· Supports GMI Directors in establishing and maintaining “best in class” and GxP compliant Med Info Services

· Oversees continuous quality assessment and improvement activities

· Support GMI Directors in Vendor Oversight and Compliance monitoring

Audit/Deviations/CAPA

· Prepares for and supports audit/inspection related activities

· Leads Deviation process together with the support of the Sub-process owner

· Leads CAPA process (together with the support of the sub-process owner) for Med Info Globally across all Biogen Affiliates

System support

· Support GMI systems optimization, testing, and process documentation

GMI Team Support

· Meeting scheduling, agenda, notes, slide preparation

· Team collaboration

Who You Are:

You thrive at leading complex, high visibility projects that could affect many different cross-functional groups globally both within medical and outside of medical (R&D etc.).  You like gaining cross-functional alignment on processes across various departments, such as Field Medical, Field Commercial, and Global Safety & Regulatory Sciences (GSRS).

• Bachelor’s/Masters/Business Administration within business or medical
• Knowledge/Certification of GxP standards preferred
• 3+ years of related experience at a pharmaceutical or biotechnology company

All your information will be kept confidential according to EEO guidelines.