HOPEWELL / PENNINGTON, NJ
HOPEWELL / PENNINGTON, NJ
- Drives the development and finalization of GCO protocol-related submission deliverables to, ensuring requirements and targets are met according to timelines and quality expectations. Serves as the subject matter expert on operational submission deliverables for the Study Report and/or Program.
- Provides clinical, scientific and operational input in operations submission documents; Partners with multi-functional stakeholders across the organization to reduce the operational complexity of the submission deliverables. Identifies opportunities for process improvement and reduction in low-value activities.
- Partners with the Clinical Trial Support Specialists for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents.
- Drives decisions and project planning for GCO study-related submission deliverables across the portfolio.
- Identifies issues and addresses responses to issues. Escalates issues regarding document risks to appropriate stakeholders and/or functional management, to expedite resolution. Proactively analyzes and drives efficient problem solving within team's control. Applies critical thinking to manage complex issues, developing mitigation and resolution strategies, and promptly responding to action items.
- Demonstrates thorough knowledge of relevant Client SOPs and policies and the ability to provide timely guidance in their application to Protocol and/or Program teams. Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to submission deliverables where applicable.
- Demonstrates strong project management skills.
- Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template).
- Degree/Certification/Licensure BS/BA Degree with approximately 4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 2 years should be in the pharmaceutical, biotech or CRO environment.
- Proven experience working on global complex regulatory submission documents.
- Proven experience driving the successful and timely execution of global clinical protocol(s) and/or related clinical documents from study start up to final clinical study report, using a defined project management framework, with a focus on writing quality documents.
- Partners with the Submissions Management Lead with submission deliverables. May lead set up and operations of discussions for the development and creation of the submission deliverables.
- Demonstrated strong project management skills.
- Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
- Strong understanding of GCPs, ICH and regulatory regulations and guidelines as they apply to protocol management and program strategy.
- Manages interactions with Senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents.
• Strong project management skills
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: email@example.com
ALPHA'S REQUIREMENT #19-00809
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE