Integration Procedural Documentation Manager - FSP
reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company 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 reputed company do.
Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company 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 reputed company and SOP authors to validate
Facilitate the risk assessment of gaps with the business and document any interim procedures to mitigate the risk
reputed company the official transition communication (using templates)
reputed company the retirement strategy
ORGANIZATIONAL RELATIONSHIPS
Head of SOPs
SOP Acquisition reputed company
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 reputed company applications (i.e., Word, reputed company, TEAMS)