Job vacancy: Clinical/Regulatory Records Manager (Actelion)

The Clinical and Regulatory Records Manager will work within the Global Drug Regulatory Affairs department, managing the paper records for Global Clinical Development with an emphasis on adherence to Good Clinical Practice (GCP). The person will:

  • Manage the inactive paper records within the Clinical and Regulatory Records Management Program and monitor records retention
  • Oversee the daily operational requirements of the internal archive
  • Manage the relationship with the external archive vendor, including oversight of contractual obligations and annual audits
  • Maintain the quality documents associated with records management in Global Clinical Development
  • Conduct regular review and assessment of the program and operations to identify opportunities and integrate best practices and continuous process improvements
  • Ensure compliance with ICH GCP and represent clinical records management at internal and external inspections and audits
  • Maintain the crisis response and business continuity plans for the records management program
  • Collaborate with Actelion Corporate Affairs and Compliance to develop and implement policies and procedures that support robust records management practices across the company and comply with applicable laws, regulations, and standards
  • Provide expertise and training on records management to staff at headquarters and at the affiliates, to support internal organizational requirements as needed
  • Provide advice to individual departments on the storage of active records so as to improve the internal flow of information and file maintenance throughout the record life cycle

Candidate Requirements

  • A qualification in records management, preferably at university level
  • Thorough knowledge and understanding of records management principles and standards (e.g., ISO), both for paper and electronic records
  • A minimum of 3 years’ experience in records management and electronic records management within the pharmaceutical industry, with a strong understanding of GCP requirements for records management and retention
  • Ability to handle multiple projects and exercise good judgement in prioritizing tasks, attention to detail and excellent organizational skills
  • Excellent communication, interpersonal and advocacy skills, and the ability to work cross-functionally and at various levels of the organization
  • Excellent IT skills and knowledge of technology used to manage records and information
  • Excellent command of English, knowledge of German would be an advantage

What Actelion Offers

  • A competitive salary and generous social benefits
  • The possibility for development and advancement within our dynamic organization
  • The innovative and stimulating atmosphere of a multicultural environment

The research facilities are located in Allschwil, Switzerland, a suburb of Basel on the borders of France and Germany.

If you are interested in applying, please make an online application via the Actelion website: http://www.actelion.com/sites/en/applicants/job-opportunities/current-vacancies.page

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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
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