Senior Change Control Specialist

Job Description

About This Role

Due to continued growth in our pipeline and a commitment to provide an uninterrupted service of our investigational medicinal products (IMP) to our patients, we are looking to identify an experienced candidate to help drive and manage Global Change Control (GCC) in our Oracle ERP system (PLM) within Biogen’s Clinical Drug Supply (CDS) organization.

We are looking for a Senior Change Control Specialist that can help our Clinical Asset Planners and Clinical Supply Managers execute on change control management that is critical for the production and delivery of IMP. This role is a critical role as we continue to optimize our supply chain efficiency and compliance. The Senior Change Control Specialist will also have opportunities to lead or support other systems-based or process-based improvement initiatives, especially for Oracle PLM.

This role will report to the Associate Director of the Clinical Supply Capabilities team.

  • Acts as Subject Matter Expert (SME) in the ownership and project management of GCC records for DS and DP changes impacting FGs. Determines when the activities that are documented in the GCC record need to be completed and manage deliverables in close cooperation with internal and external stakeholders. Works with SMEs to ensure that solutions are developed for new requirements specified in a GCC.
  • Identifies process bottlenecks and works with internal and external stakeholders to resolve issues. Identifies and communicates GCC implementation risks to Management and recommend and implement corrective actions to ensure operational efficiency, compliance, and to maintain GCC implementation due dates
  • Supports continuous improvement projects to drive process standardization and efficiency including process analysis and identification of potential solutions for improvement projects. May include support of other CDS initiatives (e.g. CDS and Digital Roadmap)
  • Coordinates and delivers training to the CDS department on systems and processes including management and creation of training content and coordinating execution of trainingfor GCC tasks.

Who YouAre

You love learning new technological skills and working through collaboration. You enjoy contributing as a SME in a role that requires an aptitude for systems and business processes.


Required Skills
  • Bachelors degree or the equivalent combination of education and experience required
  • 2+years of relevant experience

Preferred Skills
  • Reiteration offactual informationvia solid written & oral communicationskills
  • Command of MS Officesuite
  • Relationship management and project management skills
  • Systems-oriented and organized
  • ERP system such as SAP or Oracle (Oracle preferred)

Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.