Job Responsibilities
* Developing SOP mapping between sponsor SOPs and the acquiree’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.
* Demonstrated experience in project management and implementation techniques.
* GxP experience and a strong working knowledge and understanding of drug development processes.
* Required: Proficient in Microsoft applications (i.e., Word, Excel, TEAMS)
#J-18808-Ljbffr