Regulatory Reporting Specialist

Reference Number: 896353-W
Type of placement: Contract
Location: CH, NW

Introduction:

Our client is a pioneer in Drug Discovery and Development. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of manufacturing and selling of several drugs with treatment of Cancer. We are currently looking for a Regulatory Reporting Specialist for a contract to be based in Basel.

As a Regulatory Reporting Specialist you will coordinate business projects within the department, manage/source/assemble/prepare information regarding the use of the company’s products within clinical trials, on behalf of the Medical Affairs department and affiliates.

As an ideal candidate you should have 5+ years of experience in Clinical Science, Pharmacovigilance, Biometrics, Regulatory or Operations functions within the Pharma industry.

Main Responsibilities:

Communication

  • Cross-functional process review meetings;
  • Managing Global business process email account;
  • Organizing and leading Team meetings with the department  representatives;
  • Acting as one of the main contact persons for inter-departmental communication and  communication with external business partners;
  • Providing feedback to Pharma Affiliates.

Documentation and data management

  • Collecting, reviewing and distributing business process documentation and data according to the timelines; 
  • Ensuring accurate tracking of key process tools, documents (CSRs, protocols etc.) and data;
  • Running, updating trial list outputs and ensuring the quality  is according to the required standards;
  • Ensuring business process systems (CTMS, AIMS) are kept up to date and managing system support requests;
  • Archiving Clinical files and documents in the appropriate filing area.

Business Process Overview

  • Planning business process implementation phases and execution according to the timelines;
  • Building relationship with key internal and external business process  stakeholders to ensure department  needs and goals are met;
  • Coordinating regular business project activities (trial lists updates, keeping process trackers up to date, monitoring and analysing data deliverables);
  • Ensuring adherence of high level deliverables according to the timelines;  
  • Guiding, coaching and supporting junior team members if needed.

Compliance

  • Responsible for acting in line with legal, regulatory and company standards and codes of practice (eg Code of Conduct, applicable directives, guidelines and SOPs);
  • Completes all required training modules as a priority.

Qualifications and Experience:

  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • Bachelors / Masters level Scientific degree;
  • Minimum 5 years experience in Clinical Science, Pharmacovigilance, Biometrics, Regulatory or Operations functions within the Pharma industry;
  • Experience working in a cross-functional/multicultural environment;
  • Understand business process needs and able to translate needs into requirements;
  • Understand project management software ;
  • Understand drug development process;
  • Collaborative, supportive and engaging approach with people;
  • Action-oriented approach to work;
  • Strong communication and organizational skills;
  • Fluency in written and spoken English.

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