Integration Procedural Documentation Manager - FSP

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)