The Medical Operations Specialist is responsible for supporting the Medical Department in the planning, tracking and implementation of initiatives or activities related to overall medical capabilities, acting as a Subject Matter Expert in related Abbvie’s Processes and Ways we Work.

This role should provide operational and functional expertise, strategic input and high-level project management to medical activities, that include (but are not limited to) evidence generation, early access programs, financial planning processes, publication processes and management of Quality System documentation.

The main purpose is to support management and implementation of prioritized activities that enable the affiliate medical team to provide quality services to our internal and external customers, as well as to drive the continuous learning and improvement of Medical department.

CORE JOB RESPONSABILITIES

• Supports affiliate Local Evidence Teams in the preparation and conduct of the bi-annual LET meetings, across all Therapeutical Areas, in collaboration with TA Heads (as defined by the LET charter). Plays an active role in planning, managing the implementation and tracking of affiliate Local Evidence Plans.
• Works in straight collaboration with the Affiliate MHI CRAsand Local Study Teams in the execution of all Local Evidence Generation projects, in close collaboration with Local and Global Study Leads, as applicable, and according to what is defined in the LST Charter.
• In coordination with the Medical Operations Manager, develops and updates the Study Budgets for all evidence generation projects, liaising with financial department in PTP processes and oversighting correspondent invoices. Supports the management of Vendor Services contracting related to evidence generation activities.
• Collaborates in the maintenance of the local medical compliance with Quality System documentation applicable to Local Medical Affairs activities, such as procedures, working instructions, guidance’s or any other supporting documents owned by Affiliate Medical Department. Supports the Medical Operations Manager in ensuring compliance with Local Medical Affairs Training Matrix.
• Collaborates, as needed, in the affiliate Publications Processes, across all Therapeutical Areas, to support Study Leads to achieve compliance with Abbvie applicable policies and procedures.
• Supports the management of the Affiliate Pre-Approval Access Programs in liaison with Medical Operations Manager, Medical Director, TA Heads and Customer Service, ensuring compliance to Global and Local policies and procedures. Maintains related documentation tracking and archiving.

Additional RESPONSIBILITIES

• Keeps up-to-date knowledge of all appropriate processes, guidelines and regulations pertinent to this role and shares knowledge with the affiliate medical team. Enhances the operational experience by systematically capturing feedback, exploring opportunities to drive efficiencies and continuous improvement of processes, systems and solutions to meet the business needs.

• Maintains track and supports the fulfilment of requirements related to medical compliance and quality system, namely by: updating Org Charts, Job Descriptions and CVs, Form 7 fulfilment, locally owned Medical SOPs, Training Matrix or supporting documents.

• Supports local affiliate in GXP compliance within Abb Vie systems, ensuring that all study files, documentation and data are collected and maintained in line with regulatory and Abb Vie procedures.

• Supports the process of tiering HCPs in Abbvie’s FMV tool (i Hub).

• University Degree, or equivalent education in life science/healthcare or equivalent.

• Preferable to have experience in working in Medical Affairs Departments of Pharmaceutical Industry, namely on evidence generation-related activities.

• Strong ability to work in cross-functional teams and to maintain track of individual or team objectives in a matrix setting, on time and in budget – project management skills

• Strong analysis and pro-active problem-solving skills. Excellent organization skills, and ability to meet tight timelines.

• Keen interest in developing and maintaining expert knowledge for assigned processes in medical affairs and research in general.

• Strong commitment to compliance with the relevant rules and procedures, scientific quality, and integrity.

• Excellent written and spoken communication skills. Fluency in written and oral English is mandatory.

Abb Vie 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

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.