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)