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Job Description
On-site, W-2, 6 month+ contract
Within this role you will be responsible for various activities related to the preparation of periodic reports including coordination and quality control, ensuring that these reports/documents are in accordance with SOPs, regulatory requirements, and guidelines
Identify areas for process improvement, training needs and manage the change control of SOPs, supporting documents and forms for the Periodic Reporting Team.
Responsibilities
Ensure appropriate methods for checking periodic reports/associated documents (distribution documents, data requests) prepared by the Periodic Reporting Team are in place
Perform quality review of reports/associated documents in accordance with defined timelines
Complete the relevant Quality Review Checklist documenting the outcome of quality review
Discuss quality issues with relevant personnel as required o Work closely with members of the Periodic Reporting Team to identify areas where improvement in the quality of reports/associated documentation is required
Keep Periodic Reporting Team Manager informed of any issues on ongoing basis
Ensure appropriate document retention for each report produced
As part of ongoing process assessment, identify any process issues, perform root cause analysis, document issues and provide feedback to relevant parties
Request changes to Standard Operating Procedures/Supporting Documents/Model Documents and Forms if errors are discovered during the QC of reports
Identify training needs and work with relevant team members to ensure that appropriate training is provided to address these needs
Maintain in depth knowledge of relevant SOPs, regulatory requirements and other applicable documents
Ensure compliance with relevant SOPs
Maintain awareness of Company and Company drugs and knowledge of therapeutic areas
Coordinates the preparation, publication and distribution of assigned Periodic reports
Requests data from external departments (PDC, PDS, PDR, PB) /licensees required for the preparation of Periodic Reports
Coordinates the review and approval of each report
Ensures that PDR Submissions Group (RSG) are aware of all target dates for publishing
Liaises with PDR Dispatch group for Printing and Distribution of PSURs ensuring that they have all relevant documentation to dispatch PSURs on time
Tracks progress of key activities in the production of assigned reports against milestone dates.
Requirements
Excellent time management with proven ability to co-ordinate multiple assignments to tight deadlines
Flexible, Able to interact well within a team setting
Excellent attention to detail is essential
Proven experience in Quality Assurance or Quality Control
Previous experience in the use of a document management system (ideally Documentum) would be an advantage
Knowledge of medical terminology an advantage
Knowledge of drug safety regulatory obligations an advantage
Computer literacy essential
Fluent in English Ability to work within a Global Team
Proven good communication skills with an international perspective
Ability to acquire knowledge in different disease and therapeutic areas
Proactive approach to work
Able to evaluate data and draw conclusions independently
Contact
Please email Lindsey Summers at lsummers@ascentsg.com, or call at 303-694-5482.
PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry. | 
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