Manager, Medical Affairs Governance, Risk and Control

at  Alexion PharmaceuticalsInc

Location: Mississauga, Canada
Job reference: R-205710
Date posted: 08/13/2024
When we put unexpected teams in the same room, we fuel bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

PREFERRED QUALIFICATIONS:

• Experience from a life science company, specifically with Audit, Quality, Corporate Compliance, and Medical Affairs
• Strong understanding of life sciences industry risks and regulatory requirements: GxP, anti-kickback statutes, OIG compliance program guidance, FDA legislation, FCPA, UK bribery, etc., as well as demonstrated ability to apply industry guidance and standards in delivery of work product
• Relevant professional certification/degree, such as MBA, CPA, CIA, project management, six sigma
  At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients’ lives.
  Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on inclusivity in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
  Ready to lead and inspire? Apply now and take the first step towards an exciting career at Alexion, AstraZeneca Rare Disease.
  AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

THIS IS WHAT YOU WILL DO:

The Manager of Governance, Risk and Control for Global Medical Affairs will be primarily responsible for performing risk-based process effectiveness exercises to assess the function’s control environment.
This is a vital and visible role, with cross-functional impact across Medical and other functions within the Company. This role requires strong collaborative skills, knowledge of biopharma industry standards and practices, and experience in project management and process effectiveness validation (e.g. auditing, monitoring).
Candidates must also possess the ability to quickly gain trust and respect of process owners and senior leadership.

RESPONSIBILITIES WILL INCLUDE:

• Identify risk areas through robust annual risk assessment and process efficiency review planning and fieldwork.
• Lead and conduct Medical process, both GxP and non-GxP, operational and compliance effectiveness reviews (including risk-based routine monitoring, mock audits, and audit and inspection readiness assessments) according to corporate and departmental polices/SOPs and regulations, to evaluate Alexion Medical’s control environment.
• Actively develop relationships with process/control owners to build business insight.
• Establish and support, through partnering with process/control owners, first-line process effectiveness initiatives and oversight, including Medical Affairs key quality indicators.
• Work with business owners and Medical leadership to professionally communicate/present effectiveness findings, insights and recommendations, ensuring all key controls are appropriately documented and adhered to.
• Support, and at times lead, Governance, Risk and Control communications (e.g. metrics, audit takeaways, process updates, intel to advise Medical). Translate risk and continuous improvement information into clear visuals and communication tools (i.e. infographics) for Medical Affairs.
• Develop platform(s) for tools/resources (e.g. dashboard, SharePoint site).
• Maintain knowledge and understanding of pharma industry updates, regulatory guidance, and enforcement activity.