Senior Associate, Clinical Trial Submission Management

The Senior Associate, Clinical Trial Submission Management, will help ensure the technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. This vital role is assigned to one or more Amgen products under development to ensure clinical trial application approvals in the EU, delivering technical compliance with EU Clinical Trial Regulation No.536/2014 for every clinical trial submission dossier through close internal cross-functional collaboration.

Roles & Responsibilities:

• Support assembly of the submission package and supportive documentation for regulatory deliverables, for the management of clinical trials
• Be the operational driver for Clinical Trial Submissions and notifications in the state-of-the-art regulatory document management system and maintain tracking systems.
• Be the critical technical coordinator for Clinical Trial Submissions and notifications through the EMA CTIS system, performing accurate and timely input of data and documents into the EMA Clinical Trial Information System for Clinical Trial Applications, Modifications and Notifications.
• Be the Single Point of Contact for incoming EMA CTIS notifications and alerts through daily monitoring and swift dispatching of incoming requests to cross functional teams.
• Be responsible for reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teams. Ensure Requests for Information are tracked within the document management system.
• Recipient of notification of compliant events from Amgen Clinical Trial Registry System for input into CTIS within regulation timelines. Ensure efficient and timely data entry and communication of submissions to key process stakeholders.
• Submitting Clinical Trial Results to CTIS through the Marketing Authorisation Holder Access.
• Support Sponsor High Level Administrator within CTIS with access requests.
• Act as Subject Matter Expert for CTIS providing intelligence and expertise on technical submission requirements and system processes.
• Assist with definition, development, and implementation of processes to meet the evolving CTIS needs.
• Escalates, informs and resolves any issues that may impact submission process or timelines within CTIS.
• Build effective relationships and communication paths across local and functional organizations.
• Enable efficiencies and seamless execution across the EU region countries
  
  

Required Knowledge and Skills:

• Advanced technical and project management skills, demonstrated experience working in teams
• Advanced knowledge of the regulations and regulatory guidance applicable to EU Clinical Trial Applications
• Advanced knowledge of the submission and maintenance of EU Clinical Trial Applications
  
  

Preferred Knowledge and Skills:

• Advanced knowledge of Veeva Vault RIM,
• Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications
• Proven experience of working with clinical trial applications under CTR
  
  

Basic Education and Experience:

• Master’s degree and 1-2 years of directly related experience
  
  

OR

• Bachelor’s degree and 2-3 years of directly related experience
  
  

OR

• Associate’s degree and 3-5 years of directly related experience
  
  

OR

• High school diploma / GED and 5+ years of directly related experience
  
  

Preferred Education and Experience:

• Practical experience with CTIS system