When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.
- 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)