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Medical Operations Coordinator

Location:
Maidenhead
Company:
AbbVie

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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter at https://twitter.com/abbvie , Facebook at https://www.facebook.com/AbbVieGlobal , Instagram , YouTube at https://www.youtube.com/user/AbbVie and LinkedIn at https://www.linkedin.com/company/abbvie .
Medical Operations Coordinator
Based in the offices in Maidenhead reporting into the Head
of Medical Operations
Competitive salary, Bonus and Benefits package.
Fantastic working environment and development opportunities.
The company:
AbbVie is an ambitious health business where people and
quality of life come first. The experience of illness is personal, so we care
about the things that matter to patients. As market leader, we team with
partners to co-design health solutions around our innovative medicines for
complex diseases, which improve standards of care. Helping people to be fit for
work and family life is how we make a remarkable impact to the lives of men,
women and children.
Objectives:
- To provide administrative support for audits andinspections as required for Medical Division.
- To be the lead administrative coordinator for ClinicalStudies.
- Responsible for study trial master filemanagement for local studies
- To provide administrative support for the MedicalOperations Team.
- To be the lead UK super user for materialsapproval systems for both non-Promotional and Promotional Affairs MaterialsApprovals.
- Responsible for UK affiliate's retention of all regulatorycertificates for hard copy promotional materials.
- Responsible for UK affiliate training to Brandteams for life cycle management of materials
Highlighted responsibilities include:
Audits and Inspections Administrative Support
- Provide administrative support and projectmanagement support for audits and inspections for Medical Division.
- Reconciliation of records
- Set up a system for PV document review forinspection readiness
- Coordination of meetings, minutes, and follow upactions
Clinical Project Assistance
- Assists with the in-house organisation,management and execution of projects and activities undertaken by UK Affiliate
- Creates a local trial file for the filing ofCountry specific original documentation.
- Supports Medical project Manager and MedicalAffairs personnel with ethics submissions of clinical studies and related amendments,including collection of essential documents.
- Supports local Clinical Team with the handlingof Essential Documents, including Contracts and Archiving.
Materials Approval Systems - to ensure UK Affiliate remaincompliant
- Solely responsible for UK affiliate's retentionof all regulatory certificates for hard copy promotional materials.
- Solely responsible for UK affiliate training toBrand teams for life cycle management of materials
- Super User of materials approval systems.
- Training on materials approval systems, as andwhen required.
- Production and analysis of materials approvals andwithdrawals reports.
Medical Operations Team Support
- Raising, tracking, issuing PO and Chequerequests
- Preparation of contracts and associatedstatements of work and their subsequent execution and filing.
- Assistance with project co-ordination andtracking for the Department.
- Manage meetings as and when required
Qualifications
Qualifications, Knowledge and Experience
- Experience of working in pharmaceutical company or other relatedindustry
- Experience of support in audits and inspections
- Preferred is a basic knowledge related to ICH/GCPGuidelines and applicable local regulations
- Previous Administrative experience is desired
- Proven strong planning and organisational skills and theability to work effectively and efficiently in a dynamic environment withcompeting projects and deadlines
- Proven ability to manage multiple priorities/projects
- Written and verbal fluency in English and local language(if not English)
- Exhibits high level of flexibility when facing changes inthe work environment
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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