Description
We are looking for a
Regulatory Disclosures Specialist (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Redaction of company-confidential information and patient-identifying data from documents such as Clinical Study Reports and Periodic Safety Update Reports using Adobe Acrobat Professional and/or ISI Toolbox
- Monitor shared global inbox for document requests, tracking all correspondence and responding to requests in a timely and professional manner
- Coordinate with study teams and other relevant groups to acquire documents to be redacted
- Track and monitor workflows for redacted document fulfilment, logging requests and associated tasks and dates; archive completed documentation
- Actively contribute to the development and maintenance of procedures, providing assessment and feedback on redaction process, identifying and trouble-shooting process issues
- Assist in the accurate and timely posting of client's clinical trial protocols and study results to public trial registration websites
- Coordinate registry and results' record creation with contract medical writing personnel, providing documentation, contacts and work prioritization when necessary
- Facilitate adjudication of comments between teams and writers
- Write registry and results records using protocol and CSR documentation as needed
- Identify studies required for registry and results postings, including applicable trials for results posting in company trial websites, and other websites
- Liaise with project teams and other applicable groups to ensure that they understand responsibilities, timelines and deadlines, and to ensure timely review and approval of documentation for registry and results records
- Track and monitor registry and results record creation to ensure timely completion of activities; track correspondence within client via a shared global inbox
- Operate applicable systems to complete the necessary uploads
Ihre Qualifikation
- Pharmaceutical/Biotechnology industry experience
- Degree in Life Sciences or equivalent
- Experience with medical writing
- Familiarity with clinical study protocols, comprehensive results reports (e.g., Clinical Study Reports) and extensive summary reports (e.g., Periodic Safety Update Reports)
- Familiarity with Adobe Acrobat Professional and PDF manipulation techniques
- Solid understanding of the drug development process; understanding of the regulations and processes related to clinical trial disclosure
- Fluency in English
- Good knowledge of Microsoft office applications (PowerPoint, Word, Excel); organized and methodical approach to work, accuracy and attention to detail
- Desire and ability to work under minimal to moderate supervision
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager monitoring