Person2Person, LLC
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| CSR Compilation Manager Based in Northern, NJ |
| Outstanding Contract opportunity with a global pharmaceutical Company focused on multiple therapeutic areas including Neurology, Oncology and Critical Care. They continue to move forward with an entry into biologics with the development of therapeutic antibodies and other such agents, which contributes to their innovate drug discovery process. Be a part of this global market leader! |
| SCOPE & DUTIES |
Prepares documents to support Company’s clinical submissions in accordance with applicable Food and
Drug Administration (FDA) regulations, international regulatory health authority regulations, and
International Conference on Harmonisation (ICH) guidelines.
Gathers the documents required for clinical study report (CSR) appendices (e.g., site documents from
Clinical Operations, tables, patient listings, and graphs from Biostatistics, and case report forms from
Data Management), assists, as needed, with protocols, protocol amendments, investigator brochures.
Tracks CSRs, protocols, amendments, briefing books, regulatory responses, and other documents, as
applicable, through the finalization process from Prepublishing to Quality Control review, Quality
Assurance audit, eDMS release, and final publishing prior to regulatory submission.
Assists in obtaining wet signatures and e-signatures in eDMS or First Docs, as needed.
Assists with ClinicalTrials.gov registrations and updates and any other appropriate clinical study services
requested .
Drug Administration (FDA) regulations, international regulatory health authority regulations, and
International Conference on Harmonisation (ICH) guidelines.
Gathers the documents required for clinical study report (CSR) appendices (e.g., site documents from
Clinical Operations, tables, patient listings, and graphs from Biostatistics, and case report forms from
Data Management), assists, as needed, with protocols, protocol amendments, investigator brochures.
Tracks CSRs, protocols, amendments, briefing books, regulatory responses, and other documents, as
applicable, through the finalization process from Prepublishing to Quality Control review, Quality
Assurance audit, eDMS release, and final publishing prior to regulatory submission.
Assists in obtaining wet signatures and e-signatures in eDMS or First Docs, as needed.
Assists with ClinicalTrials.gov registrations and updates and any other appropriate clinical study services
requested .
| REQUIREMENTS |
Bachelor's or Master's degree. 5 years recent experience in the pharmaceutical industry. Previous
experience as a medical writer, clinical operations/study manager, submissions manager, or regulatory
affairs manager.
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |