Regulatory Reporting Specialist
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.
- 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.
- 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.