Medical Operations & Evidence Generation Specialist

DEPARTMENT FUNCTION AND OBJECTIVE

The local Medical Operations & Evidence Generation Team based in the Medical Department of the Saudi Affiliate (Medical Director Medical Operations & Evidence Generation Manager Medical Operations & Evidence Generation Specialist) has the overall responsibility for the development and execution of the Affiliate Medical Operations & Evidence Generation strategic plans.

PRIMARY FUNCTION

• To provide set-up coordination and execution of centrally or locally sponsored international and local Non-Interventional Studies (NIS) as a member of the Medical Department of AbbVie in the Affiliate.
• Reporting to the Medical Operations and Evidence Generation Manager this position represents the country/region expertise for post-marketing observational and other non-interventional studies. The position provides operational advice/guidance to the Affiliate Medical Affairs organization for multi-country or local projects.
• Work with the Medical Director to ensure that the Medical Department delivers value to the affiliate patients and the medical community through excellence in the planning and execution of medical projects and activities in preparation for launches (Launch Readiness) leadership of the Gap Assessment and medical anchors of the Brand Plans in-field medical team effectiveness evidence generation medical education and all medical initiatives. Ensure the quality of processes and compliance in the Medical Team through the development and control of procedures and documentation conducting audits of service providers conducting internal audits in accordance with local regulations and global requirements of AbbVie.

MAJOR DUTIES AND RESPONSIBILITIES

Clinical Research and Evidence Generation

• To lead the development and execution of different types of evidence generation: non-interventional studies Pharmacoeconomics studies epidemiological studies Real World Evidence in collaboration with internal stakeholders including but not limited to Medical and Market access.
• To ensure the development of the affiliates evidence generation project plans.
• To manage the selection process of research sites and investigators ensuring the engagement of investigators and institutions of high scientific relevance and in accordance with the corporate strategy.
• To support Medical Managers/Medical Director so that the evidence generation projects are aligned with the global and local strategies of the products and Therapeutic areas of interest responding to scientific gaps validated with the brands teams of the affiliate.
• To ensure that all evidence generation procedures are in compliance with the regulations in force and SOPs in the area (local and global).
• To ensure budget planning and control of evidence generation projects investigator-initiated studies as well as adequate payment from researchers research sites and service providers.
• To support scientific partnerships with medical institutions and societies for scientific records non-interventional studies database analyses and other projects involving external collaboration.
• To ensure that Evidence Generation service providers are qualified monitored/audited in accordance with AbbVie guidelines and local regulations.

Publications

• Serve as an Affiliate Publication Co-Lead.
• Ensure that the Affiliates Publication Plan is aligned with the Gap Assessment and Brand Plans.
• Support the development of scientific publications: results of local/regional studies sub-analyses of global studies pharmacoeconomic studies database analysis bibliographic reviews and others. 
• To ensure that local scientific publications are developed in accordance with AbbVies policies.
• To ensure that external authors have authorship criteria to manage so that activities related to publication are carried out in accordance with AbbVies policies.

Medical Operations

• Support MO&EG Manager in development and implementation Key Performance Metrics to measure the value and impact of Medical Affairs activities ensure accurate and timely reporting to key business partners
• Support MO&EG Manager to plan and manage budget for the Medical Department
• To ensure the planning and maintenance of the Medical Teams quality process.
• To manage the development of strategies and planning for internal and external audits.
• To ensure the process of periodic development control and updating of the Medical Teams organizational documents: organization charts job descriptions signature logs CVs.
• To perform overall Risk Assessment of Medical related activities and advise MO&EG Manager on specific actions that need to be in place and not limited to interactions of Medical In-Field Team with HCPs Promotional and Non-Promotional materials Fair Market Value Tiering etc.
• Collaborate with cross-functional business leaders regarding HEOR processes solutions and initiatives to achieve shared business objectives. 

Others:

• Undergo and maintain training as required by Global Clinical Operations and other relevant company procedures to ensure adherence to ICH GCP AbbVie GPRD SOPs and IQS processes and procedures local SOPs applicable regulatory requirements and study specific needs.
• Collect information from the market regarding market condition changes registration regulations / guidelines etc. changes and forward them to the direct supervisor regularly.
• Provide operational guidance where needed.
• Contribute to achieve satisfactory study audits.
• Ensure appropriate local SOP are in place to cover NIS conduct in the affiliate.

KEY INTERNAL AND EXTERNAL INTERFACES

Interacts with builds and maintains professional and collaborative relationships with:

• Affiliate medical personnel: Head of Medical Affairs/Medical Director; Medical Operations and Evidence Generation Manager Medical Managers/Advisers; Medical Science Liaison; Affiliate Safety Representative / drug safety personnel and Clinical Research Admin
• Clinical Site Management: Country Clinical Operations Head Clinical Research Associate and Country Study Startup Specialist
• Other affiliate personnel: regulatory affairs finance legal etc.
• Area based Therapeutic Area medical affairs teams.
• Area Medical Affairs teams
• Participating research Investigators and study personnel; thought leaders/external experts.
• Hospitals other healthcare providers Ethics Committee and Local Regulatory Authorities.
• Third party vendor (e.g. CRO data management)

Qualifications :

• Appropriate medical background or healthcare-related qualification or experience.
• Typically of 5 years Clinical Research experience of which at least 3 years must be in clinical research monitoring including demonstrable experience in clinical study coordination or management.
• Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Written and verbal fluency in English and Arabic.
• Acute observational skills analytical and conceptual capabilities.
• Exhibits high degree of flexibility when facing changes in the work environment. Attention to details and strong interpersonal skills.
• Competence in the use of personal computers including experience with word processing spread sheets email and web-browser applications.
• Ability to work independently with minimal supervision.
• Ability to travel regularly (approximately 25%)
• Experience in Medical Operations is preferred  
• Excellent knowledge of regulations governing clinical research ICH/GCP Guidelines and all applicable local regulations.
• Good knowledge of standard IT office tools: MS Office (Excel Word PowerPoint Project Access Adobe Acrobat).
• Knowledge of statistical programs such as SAS Statistica R PASS Stata etc. is preferred.
• Managing obstacles using strong problem-solving skills

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:

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