Specialist, Regulatory Compliance

Requisition Number: 6322

Position Title: Specialist, Regulatory Compliance

External Description:

SUMMARY: The Specialist, Regulatory Compliance is a global position responsible for performing quality review and approval of essential documents in compliance with the relevant Standard Operating Procedures, country regulations and industry best practice prior to initiation of study sites. 
  
RESPONSIBILITIES: 
Tasks may include but are not limited to: 

• Receive, review, process and file essential documents, part of the Essential Document (ED) package agreed for the study, in accordance with applicable local regulations, internal SOPs and guidelines and ED Review Plan.
• Check the completeness of the ED packages as well as the quality of the documents provided
• Communicate corrective action and ensure issue resolution to meet documentation requirements as required, prior to approval of the ED packages and ED checklist sign off.
• Complete/updated relevant tracking tool on ongoing basis to allow visibility to project teams on the ED review progress status.
• Prepare and submits electronic copies of approved site ED, part of the ED Package for filing in Trial Master File, as applicable.
• Work with a variety of Electronic Document Management Systems to review and approve ED, as needed. 
• Escalate any quality issues in a timely manner to relevant parties.
• Perform additional tasks as assigned by their Line Manager

 
Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
 
 
OTHER SKILLS AND ABILITIES:  

• English written and spoken, advanced level
• Strong organizational and time management skills
• Exercise sound judgment and ability to identify decisions requiring supervisory approval
• Handle multiple tasks with exceptional accuracy
• Computer literacy in Microsoft Word and Excel

 REQUIREMENTS:
 

• University degree preferred (Life Science desirable) and 2 year of relevant experience or
• Combination of education and 3 years of relevant experience 

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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Employment Type: Regular

Community / Marketing Title: Specialist, Regulatory Compliance

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Belgrade, RS

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