Job Posted: 18 Jan 2017

Process Optimisation Manager - Medical Affairs EMEA

Competitive| Berkshire, Buckinghamshire, Surrey, Hampshire, Middlesex, West Sussex| Permanent

JOB SUMMARY:

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.

 

BACKGROUND:

Global organisation – top 20 pharma

Highly visible role across global organisation

Brand new role

 

PRIMARY DUTIES 

  • 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.

 

Benefits:

Corporate

 

TO APPLY:

For a confidential discussion please telephone Anette Gillan at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-6750

 

KEYWORDS:

Senior Process Optimization Manager, Senior Process Optimisation Manager, Senior Process Optimisation, Senior Process Optimization Manager, Manager Global Medical Affairs, medical affairs. Change management, process change management, quality documents, quality, medical affairs management, medical affairs process, SOP, Standard Operating Procedure. Process improvement, GCP, GXP, clinical development, clinical, QA, Quality Assurance, SOP, SOPs, standard operating procedures

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market