Submission Senior Specialist
4 days ago
Description
data in Workday, appropriate source per department or a contractor agreement.
• Typically 5-9 bullet points; each describing a distinct and primary responsibility of the role.
• Avoid generic comments such as “works well with others”, etc. • Tracks, collects, and reviews all components for submission to Health Authorities.
• Interacts with responsible parties for quality submission documents for submissions.
• Facilitate submission team meetings with team support.
• May participate in focused projects related to their scope of work.
• Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission).
• Attend Submission Team and kick off meetings, represent RISM and drive submission publishing timelines.
• Coordinate Initial IND Kick off meeting submission.
• Coordinate IND, NDA, BLA and Orphan Drug Annual Reports.
• Develop/Update job aid documents for departmental process.
• Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist).
• Coordinate non-eCTD submissions with International Regulatory Team lead.
Degree Requirements
BA/BS degree, science / technology field preferred
Experience Requirements
3+ years relevant submissions experience
Key Competency Requirements
Key Competency Requirements • Foundational knowledge of global regulatory practices, submission guidelines and requirements.
• Assists in the implementation of short- and long-term goals within own work group within RISM.
• Come prepared with a solution to questions and issues as they arise.
• Engages relevant stakeholders to help address the problem.
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.
• Demonstrates basic presentation skills needed to deliver content to a variety of audiences.
• Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail.
• Communicates project status and updates, as appropriate, to relevant stakeholders.
• Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives.
• Proposes alternative solutions for submission-related and/or project situations.
• Seeks to understand stakeholder needs, priorities, working processes, and activities.
• Good understanding of desktop application software suites.
• Knowledge and some experience of computer systems in an R&D environment .
#HYDDD
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