Archivist (m/f)

Job description

Job Description

• Ensure quality, inspection-readiness, timeliness and efficiency of facility management and document processing standards local archival facilities in accordance with Health Authorities’ guidelines, Good Clinical Practices, Novartis internal standards
• Manage archiving of Trial Master File (TMF) / Product Specification File (PSF) and other regulatory records with long-term retention periods in cooperation with business representatives
• Ensure oversight and control over archived GxP essential documents appropriately according to GxP and applicable SOPs
• Manage archive services provided by external partners, including but not limited to site management and off-site archival.
• Support the creation and/or update of applicable SOPs, Guidance Documents, templates etc., as applicable
• Support the transition of knowledge about adherence to archiving regulations into the respective line organizations, i.e. ensure training and support activities for business functions
• Manage support processes for document management related requests from business functions, which may include Legal requests, In/Out Licensing projects, and audits/inspections
• Continuously oversee and identify rooms for improvement for document management processes, in particular in the areas of archiving and TMF management. Support implementation activities as applicable.
• Support implementation of electronic TMF archiving systems & processes
• Promote best documentation practice to line functions to ensure that documents created/generated in the course of clinical research are managed and archived in accordance with GCP guidelines and applicable SOPs
• Support audits and health authority inspections by providing in-person as well as back-office support
• Liaise and cooperate with stakeholder functions within Global Drug Development (GDD)
Position Title

Archivist (m/f)

Desired profile

Minimum requirements

• Life science university degree or education in life sciences
• Fluent English (oral and written)
• At least 2 years of relevant clinical research/pharmaceutical industry experiences, incl. handling GxP-relevant documents
• Knowledge of the technical requirements by FDA/EMA for submission documents
• Knowledge of and experience in global regulatory environment and guidelines impacting paper and electronic archiving processes
• Good computer skills (MS Office) and overall understanding of processes embedded in technical applications
• Knowledge of the clinical drug development and international drug approval processes and related document requirements.
• Good organizational and communication skills
• Attention to detail and a structured way of working
Job Type

Full Time
Country

Germany
Work Location

Oberhaching (near Munich)
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

GDO GDD
Employment Type

Regular
Company/Legal Entity

Hexal AG