Regulatory Operations Assistant - Munich, Germany

Company
Synteract
Location
Germany
Salary
Competitive
Posted
27 Apr 2021
Closes
27 May 2021
Ref
29061
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Regulatory Operations Assistant - Munich, Germany

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

The Regulatory Operations Assistant is responsible for providing administrative support to the Regulatory Operations team in preparing submissions to Ethics Committees/Institutional Review Boards, Competent Authorities and Local Authorities.

Specific tasks would include:
  • Performs administrative tasks associated with preparing and executing the submission of study documents to the relevant
  • EC/IRBs, R&D, Regulatory Authorities and Local Authorities.
  • Arranges translation of regulatory documents, if required.
  • Assists operational staff in forwarding the corresponding documents for the investigator file and attends project team meetings, if needed.
  • Assists the pharmacovigilance team with safety reporting, if required
  • Contributes to the company's Regulatory Intelligence database and supports the Regulatory Intelligence Officer, as needed.
  • Performs the filing all regulatory documents (as part of the Trial Master File).
  • Takes meeting minutes.
  • Assists with the translation process of documents.
  • Ships and tracks documentation and material.
  • Supports the Regulatory Operations team in the execution of regulatory projects.
  • Ensures compliance with Regulatory Agency rules and guidelines pertaining to regulatory submissions (paper and electronic).
  • Performs copying, filing, scanning, and sending of documents.


Qualifications
  • High school/secondary level education required. Some applicable experience desired, not required.
  • Fundamental knowledge base in the conduct of clinical trials with focus on essential documents is an asset.
  • Basic proficiency in MS Office to include Word, Excel, Outlook, and PowerPoint.
  • Effective verbal and writing skills; English + local language, if relevant.

If you're passionate about clinical trials, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, colour, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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