Medical Operations Coordinator

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

MISSION:

The Medical Operations Coordinator supports the teams vision and leadership of the Medical Operations Team. They execute these responsibilities by utilizing experience, understanding of the regulatory landscape, passion and creativity to provide patient-centric and compliant operational expertise in line with AbbVie’s vision. They support the best interests of patients, the Affiliate and AbbVie within the country with regard to interactions with internal and external partners. They contribute to the department's overall success by enhancing the user experience by systematically capturing feedback, exploring opportunities to drive efficiencies, and continually improving processes, systems and solutions to meet the business needs.

Materials Approval System Super User Lead

• Collaborate with departments and external vendors to ensure smooth onboarding and off boarding of user access to the materials approval systems.
• Collaborate with material owners, reviewers and manager to create and maintain training guides for efficient and complaint approvals.
• Training for staff on system requirements.
• Collaborate with Global Systems Lead on systems update and communicate proactively to the affiliate on upcoming changes.
• Liaises with internal teams and third-party vendors to maintain access to materials approval systems.
• Production and analysis of materials approvals and withdrawals reports.
• Responsible for accurate data keeping/entry into the materials approval system.

Compliance  & Metrics

• Tracking of exception reports.
• Tracking of ABPI Code training.
• Ensures the UK therapeutic affiliate’s retention of all regulatory certificates for hard copy promotional materials.
• Reconciliation of hard copy certificates and archiving in a timely fashion
• Highights issues to senior managers and inputs into management review meetings
• Provides effective resolution of issues occurring within the UK on materials approvals and life cycle management.

Audits/Inspections:

• • Participates in pre-audit activities to meet Audit requirements.
  • Supports affiliate in managing organisation/planning/logistics/reports for audits/inspections
• Ensures efficient document management to GxP standards to enable audit and inspection readiness
• Manage and maintain records for medical operation processes.

Other Medical Operations Systems and Records Management

• Responsible for partnering with the assigned affiliate Medical Operation Team(s) member to
  • record key information to processes
  • review records for compliance
  • train on relevant systems updates
• Management of meetings as and when required.
• Provides operational support as needed for the Medical Operations Function

ACCOUNTABILITY

• To use company administration systems and processes in line with policies and guidelines.
• To comply with the Company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.

GENERAL ACCOUNTABILITIES

To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.

Responsible for the health, safety and environmental performance of themselves and others through compliance within EHS programs, regulations and standards. Subject to the policy and procedures outlined in the EHS Handbook.

BACKGROUND/EDUCATION

Education:        

• Science Degree Essential
• Desirable: project management qualifications/qualifications in IT systems

Previous Experience & knowledge:

• Ability to think and plan and to adopt an open-minded approach to challenges.
• Collaborative, team-oriented approach, able to develop and support relationships across an organization.
• Excellent written and spoken communication and presentation skills.
• Sound judgment, strong planning and organizational skills, and the ability to get things completed.
• Works independently: limited guidance/oversight
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
• Project Management Skills desirable or proven experience of undertaking an undergraduate project requiring these skills.
• Ability to understand pharmaceutical and medical terminology.
• Training or customer facing role experience desirable.
• Computer and software knowledge like MS Office (Word, Excel, PowerPoint, Outlook, Share-point)

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html