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Regulatory Affairs Consultant
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Marketing, Consultant
Projektbeschreibung
Scope
The mission covers business analysis activities to fulfil the Article 57 requirements that fall under the EU Regulation 1235/2010, also known as XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) and IDMP (Identification of Medicinal Products) in Europe.
Primary activities include, but are not limited to:
- XEVMPD Enhancements
- Participation to the enhancements of the XEVMPD solution, including data mapping and process updates, using the authoritative source for Registration based on Liquent Insight, and to support the Falsified Medicines Directive in Europe
- IDMP Data Remediation
- Coordination of activities to prepare and collect information included in scope of IDMP Iteration 1 in Europe, in close collaboration with European affiliates and a number of departments (eg CMC)
- Activities cover coordination, pilot, documentation, training, support, and follow-up
- IDMP To-Be Processes
- Participation to the definition of to-be IDMP processes, covering essentially the European regulatory aspects, possibly extended to other countries (eg Switzerland)
The mission will be conducted in close relationship with the IDMP Global Business Lead (US-based), the IDMP Regional Business Lead (Brussels-based), the XEVMPD Data Stewards, the Regulatory Affairs department (Regional Center and Affiliates), departments within HQ (CMC, IT ), and the European Authorities.
Specific requirements (skills) or experience for the assignment
Education:
- Bachelor degree
- Background in Regulatory Affairs Operations and/or Information Technology is a plus
General experience:
- English is required at a fluent level
- Knowledge of other European languages is very desirable
- Attention to details, deadlines and quality is key
Relevant business experience is desirable in the following domains:
- Knowledge of European regulatory environment including all marketing authorization types (Centralized, Mutual Recognition, Decentralized and National Procedures), Initial Marketing Applications and Post-Approval Procedures, eCTD (Electronic Common Technical Document), Electronic Application Form (eAF), Regulatory Information Management systems (RIM)
- Pharmacovigilance regulation (Regulation EU 1235/2010) including IDMP and/or XEVMPD
- Product information (structure of information on medicinal products and substances)
- Experience in multicultural organizations
Project experience:
- Business analysis and/or project management within large organizations
- Exchange standards in compliance with international regulations (Information Model)
- Document and records management, content management
- Online transactional processing systems and tracking systems
- In relation to the relevance of the project, 5 years in the business domain are required
The mission covers business analysis activities to fulfil the Article 57 requirements that fall under the EU Regulation 1235/2010, also known as XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) and IDMP (Identification of Medicinal Products) in Europe.
Primary activities include, but are not limited to:
- XEVMPD Enhancements
- Participation to the enhancements of the XEVMPD solution, including data mapping and process updates, using the authoritative source for Registration based on Liquent Insight, and to support the Falsified Medicines Directive in Europe
- IDMP Data Remediation
- Coordination of activities to prepare and collect information included in scope of IDMP Iteration 1 in Europe, in close collaboration with European affiliates and a number of departments (eg CMC)
- Activities cover coordination, pilot, documentation, training, support, and follow-up
- IDMP To-Be Processes
- Participation to the definition of to-be IDMP processes, covering essentially the European regulatory aspects, possibly extended to other countries (eg Switzerland)
The mission will be conducted in close relationship with the IDMP Global Business Lead (US-based), the IDMP Regional Business Lead (Brussels-based), the XEVMPD Data Stewards, the Regulatory Affairs department (Regional Center and Affiliates), departments within HQ (CMC, IT ), and the European Authorities.
Specific requirements (skills) or experience for the assignment
Education:
- Bachelor degree
- Background in Regulatory Affairs Operations and/or Information Technology is a plus
General experience:
- English is required at a fluent level
- Knowledge of other European languages is very desirable
- Attention to details, deadlines and quality is key
Relevant business experience is desirable in the following domains:
- Knowledge of European regulatory environment including all marketing authorization types (Centralized, Mutual Recognition, Decentralized and National Procedures), Initial Marketing Applications and Post-Approval Procedures, eCTD (Electronic Common Technical Document), Electronic Application Form (eAF), Regulatory Information Management systems (RIM)
- Pharmacovigilance regulation (Regulation EU 1235/2010) including IDMP and/or XEVMPD
- Product information (structure of information on medicinal products and substances)
- Experience in multicultural organizations
Project experience:
- Business analysis and/or project management within large organizations
- Exchange standards in compliance with international regulations (Information Model)
- Document and records management, content management
- Online transactional processing systems and tracking systems
- In relation to the relevance of the project, 5 years in the business domain are required
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Organisation/Management