Archivist (m/f) - SANDOZ - Oberhaching - Wizbii

Archivist (m/f)

  • Durch SANDOZ
  • Unbefristeter vertrag
  • Oberhaching (Germany)
  • Sekretariat / Verwaltung
2018-05-17T20:57:16+0000

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)

Seeked 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

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About SANDOZ

Sandoz, une division de Novartis, est un leader mondial parmi les fabricants de médicaments génériques. Sandoz (26400 collaborateurs répartis parmi 130 pays avec un CA de 9.6 milliards USD en 2014) met à disposition des patients et des professionnels de santé des médicaments de qualité dont les prix maitrisés facilitent l’accès aux soins et contribuent à l’optimisation des dépenses de santé. Sandoz France fonde son développement sur la confiance des patients, de ses clients, de ses partenaires et appuie son succès sur : une recherche permanente de l’innovation, tant pour ses produits (génériques et biosimilaires) que pour ses actions ; Un portefeuille large, qui inclut une offre croissante de biosimilaires et qui répond aux besoins essentiels de santé publique ; Le savoir-faire industriel du Groupe Novartis, et de plus de 40 partenaires français ; L’engagement d’équipes fières et responsables, réunies autour d’une vision commune et de valeurs partagées.

1114 vacancies open at SANDOZ

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