Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Integration Procedural Documentation Manager - FSP
Job ID R0000040342 , South AfricaJOB 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)
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