Job as Senior PK Analyst in Parexel

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PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.

Post: Senior PK Analyst

Job Description
The Team Leader, PK Analyst shall lead a given team or group. He/She shall mentor staff members and shall provide management support to the line manager. This support shall include project and resource management of projects in their operational area. The Team Leader may be part of a functional team and act as a lead PK Analyst. The Team Leader will work under close supervision of the responsible line manager and may directly provide line management support for the functional team.

Key Accountabilities
• Oversee team activities including:
- Appropriate resourcing of staff in specified location and according to Global resourcing Processes, including assessing resource availability, project needs and needed labor hours
- Implement and oversee required quality control of project deliverables
- Ensure timely delivery of project deliverables and early flagging of possible risks to line manager
• Monitor performance of assigned team members
• Identify and implement training (together with line manager), mentor and allocate team members according to their ability and needs
• Give input into the writing of PK sections of study documents for clinical conduct and/or submission to North American and European regulatory authorities, including but not limited to: statistical analysis plans, clinical development plans, human experience summaries, human pharmacology summaries, investigator brochures, study protocols, interim and final clinical study reports, CTD clinical overviews and summaries, safety updates, integrated summaries of safety and efficacy.
• Perform WinNonlin analysis of concentration-time data for PK and PD data files
• Coordinate team review and sign-off of PK deliverables according to PAREXEL guidelines/SOPs including: drafts of documents, revisions, concentration-time input files and WinNonlin analysis parameter output.
• Serve as the PK analyst representative on assigned project teams, providing proactive support to Project Management for planning efficient work plans and timelines for PK deliverables. Identify any potential project challenges to departmental line management and project manager including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
• Provide PK editing review of draft and final documents prepared by medical writers before internal or external distribution. This includes content review.
• Ensure document content adheres to FDA/EMEA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and department guidelines.
• Perform literature searches/reviews as necessary to obtain background information for development of documents including: study proposals, study synopses, protocols, clinical study reports, etc.
• Attend internal technical team and client team meetings as required.
• Provide training and guidance and act as a mentor to less experienced departmental members.
• Assist management as needed with preparation of resourcing estimates for potential new projects.
• Assist management as needed in reviewing request for proposal packages sent by clients to determine content and appropriateness of materials required for development of clinical documents.
• Initiate and participate in departmental or interdivisional process improvement and training initiatives.
• Initiate and manage development of formats, templates and general guidelines for PK analysis documentation and workflow procedures. Assist in the development of departmental SOPs.
• Keep abreast of professional information and technology through workshops and conferences, and assure the appropriate transfer of that information to the department.

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