Process Optimisation Manager - Medical Affairs EMEA
Competitive| Berkshire, Buckinghamshire, Surrey, Hampshire, Middlesex, West Sussex| Permanent
This is a key, influential role that will engage Medical Affairs colleagues in affiliates and take responsibility for reviewing and coordinating the improvement of operational processes across medical affairs and clinical operation functions. This will include reviewing, authoring and editing of quality documents. This is suited to a Quality Assurance or clinical professional with experience in GCP.
Global organisation – top 20 pharma
Highly visible role across global organisation
Brand new role
- Author, edit, gain approval and deploy Quality Documents (QDs) [e.g. standard operating procedures (SOPs), and/or other working practice or associated guidance documents].
- Support process improvement initiatives to address complex problems and provide solutions to EMEA affiliates.
- Support process improvement activities within the Clinical Operations function of Medical Affairs-EMEA and across affiliates.
- Support functional Medical Affairs-EMEA Operations objectives:
- Maintain standard tools, methodologies and templates to support Medical Affairs-EMEA process optimisation activities.
- Monitor activities and resources, as required.
- Provide clear and concise communication to Medical Affairs staff and external partners.
- Ensure processes align and comply with regulatory requirements and global processes.
- Work closely with company training groups to support development of training materials to affiliates.
- Support the global initiatives as directed by Director.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- Bachelor’s Degree or equivalent in science or health-related field.
- A quality or clinical professional experience within GCP
- Knowledge and experience in clinical operations activities.
- Understanding of ICH/GCP, FDA/EMEA regulations and strong knowledge/application of good document management practices
- Possess excellent organisational and interpersonal skills, strong verbal and written communication skills, and the ability to adjust to changing priorities.
- Comfortable in a fast-paced environment.
- Demonstrated ability to develop and maintain effective relationships with team members and internal/external partners.
- Knowledge and/or experience working with groups with varied cultural backgrounds and learning styles.
For a confidential discussion please telephone Anette Gillan at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-6750
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