Medical Operation Specialist

Amadora - Portugal

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

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 Abbvies 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 CRAs and 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 guidances 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 AbbVie systems ensuring that all study files documentation and data are collected and maintained in line with regulatory and AbbVie procedures.
Supports the process of tiering HCPs in Abbvies FMV tool (iHub).

Qualifications :

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.

Additional Information :

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

Work :

Employment Type :

Full-time

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 CRAs and 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 guidances 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 AbbVie systems ensuring that all study files documentation and data are collected and maintained in line with regulatory and AbbVie procedures.
Supports the process of tiering HCPs in Abbvies FMV tool (iHub).

Qualifications :

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.

Additional Information :

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

Work :

Employment Type :

Full-time

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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