Integration Procedural Documentation Manager - FSP
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At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.
reputed company 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 reputed company
ORGANIZATIONAL RELATIONSHIPS
Head of SOPs
SOP Acquisition reputed company
Business Process Owners (BPOs) for clinical, medical, safety, regulatory and reputed company management system process areas
SOP Authors for clinical, medical, safety, regulatory and reputed company management system process areas
reputed company organization colleagues
Sourcing Risk & Compliance
Project Management Office (PMO) Colleagues (PMOs are established per business deal)
QUALIFICATIONS / SKILLS
BS/BA Degree plus 5+ years reputed company 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)