Documentation Quality Control Specialist

The purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients.

Headquartered in Switzerland – a biotech-hub of Europe – Idorsia is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.

We are looking for a Documentation Quality Control Specialist to join the Documentation Group of the Drug Regulatory Affairs Function.

Job Responsibilities

• Reviews clinical and regulatory documents (including Protocols, Investigator’s Brochures, Clinical Study Reports, Annual Safety Reports, Product Information, etc.)  to determine whether they are clear, concise, consistent, complete, in line with source data, and in accordance with ICH and regulatory authority guidelines and Idorsia procedures and templates. Ensures that such documents are suitable for inclusion in critical regulatory submissions, e.g., NDA, MAA, IND, etc.
• Interacts with authors and contributors from Global Clinical Development and other functions as needed to continuously improve the quality of clinical and regulatory documents
• Contributes to the development and implementation of templates and guidelines for clinical documentation.
• Contributes to due diligence activities if requested by the Regulatory Lead.
• Negotiates contracts with external Regulatory Documentation Quality Specialists and manages the collaboration, including allocating their work and managing the quality and timely provision of deliverables.
• Coaches and mentors both external consultants and aspiring Documentation Quality Specialists in documentation quality control.

Candidate’s Requirements

• Postgraduate qualification, preferably in a science-related field.
• Excellent spoken and written English.
• Good understanding of experimental methods, research design, and statistical analysis.
• Ability to analyze and interpret medical data obtained in a clinical trial.
• High degree of accuracy and attention to detail.
• Excellent MS Office skills.
• Knowledge of regulatory document requirements/guidelines.
• Ability to work independently.
• Excellent communication and interpersonal skills.
• At least 2 years previous experience in clinical and/or nonclinical quality assurance, or writing and/or editing of clinical and/or nonclinical documents.

Work Location: Basel Area

Country: Switzerland

Business Area: 

Job Area : Documentation Group - Drug Regulatory Affairs - Global Clinical Development

Schedule: Fulltime

Job Type: Permanent

Job Id :4746

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.