パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Integration Procedural Documentation Manager - Poland - FSP
応募 求人ID R0000040376 ロケーション ポーランド共和国 仕事内容JOB RESPONSIBILITIES
Developing SOP mapping between sponsor SOPs and the aquiree’s sponsor/contract research organization (CRO)/vendor procedural documentation
Conduct comparison assessments between the procedural documentation to identify major gaps and work with the business process owner and SOP authors to validate
Facilitate the risk assessment of gaps with the business and document any interim procedures to mitigate the risk
Develop the official transition communication (using templates)
Develop the retirement strategy
ORGANIZATIONAL RELATIONSHIPS
Head of SOPs
SOP Acquisition Lead
Business Process Owners (BPOs) for clinical, medical, safety, regulatory and quality management system process areas
SOP Authors for clinical, medical, safety, regulatory and quality management system process areas
Quality organization colleagues
Sourcing Risk & Compliance
Project Management Office (PMO) Colleagues (PMOs are established per business deal)
QUALIFICATIONS / SKILLS
BS/BA Degree plus 5+ years Pharma experience.
GCP experience (5 years); process management, project management, SOP writing.
Demonstrated experience in project management and implementation techniques.
GCP experience and a strong working knowledge and understanding of drug development processes.
Required: Proficient in Microsoft applications (i.e., Word, Excel, TEAMS)
