Senior Manager, Global Medical Information Operations

Senior Manager, Global Medical Information Operations  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire 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.

The Sr. Manager, Global Medical Information (GMI) Operations will be responsible for day-to-day activities to support process improvements within GMI. This individual will collaborate with Quality & Compliance, Medical Affairs Operations, Regulatory Labeling, Training, IT, and International Stakeholders to ensure implementation of best practices, long-term planning, quality, and compliance with policies and standard operating procedures (SOPs) globally.  Collaborate and coordinate vendor activities to ensure adherence to established SOPs, key performance metrics are achieved, and staff is appropriately trained.  Assist in the development and management of all applicable SOPs, working practices/instructions, training materials and ensure that information is communicated appropriately to GMI, contact center vendors, and internal stakeholders.

You will be responsible for:

• Serve as a core team member performing all day-to-day operational activities, including but not limited to coordinating, scheduling and facilitating meetings; providing support for the Medical Information contact center including staff on/off-boarding; planning and execution of process improvement activities to increase department efficiency and quality.
• Track and coordinate the development/updates of departmental trainings and manages internal documents (SOPs, working practice documents) in support of the GMI process.
• Work collaboratively with IT business partners to ensure system changes are implemented and applicable controls are documented when required; assists with the digital transformation of GMI and integration into AstraZeneca platforms.
• Supports inspections/audits of both internal GMI and third-party vendors conducted by R&D Quality and/or regulatory health agencies; facilitates submission and resolution of deviations and CAPAs for the department.
• Provides input on the tactical budget planning process and manages invoices and accruals on a monthly basis; supports the contract approval and purchase order requisition process.
• Assists medical information leadership team on developing and generating metric analyses, including reports describing progress towards achieving Key Performance Indicators (KPIs).

You will need to have:

• Bachelor’s Degree (B.S.)
• 3-5 years of professional experience in the pharmaceutical industry
• Demonstrated project management skills.
• Experience in developing work practice documents, SOPs and effective training materials.
• Experience and in-depth knowledge of medical information systems, call center operations, including experience establishing global functionality; experience working with and / or providing oversight to medical information service providers /vendors.
• Understanding of drug development, global and local regulations and reporting requirements for adverse events and product complaints reporting; experience in associated audits and inspections
• Experience working with validated systems and the change control process.
• Exposure to various systems such as SharePoint, Box, Smartsheet, Trackwise, Veeva Vault, Salesforce, and data analytics software; proficient with PowerPoint presentations
• Excellent written and verbal communication skills
• Self-motivation to drive for results, with strong organizational and planning skills.
• Ability to travel to meetings.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Strong interpersonal skills and tactful negotiation skills in addition to excellent verbal and written communication skills
• Project management skills with proven ability to prioritize, conduct, and meet project deadlines.
• Operational management experience with ability to determine essential components of requirements in order to include them in applicable policies, standard operating procedures (SOPs), working practice/working instructions, and training materials.
• Effective organizational and time management skills
• Demonstration of ability to learn quickly (strong learning agility)
• Experience configuring/managing a database and working and partnering with IT colleagues to implement solutions.

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.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

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.