ProClinical is advertising a vacancy for a Documentation Specialist position with an outstanding multinational healthcare company. This company, which prides itself on its innovative range of diagnostic solutions and medicines, is seeking for the incumbent to join their family in Switzerland on a contract basis.
The Documentation Specialist will support and provide coordination, compilation, and publishing expertise in the preparation of the nonclinical section of regulatory applications (Module 4) including initial applications (INDs, NDAs, etc) and other submissions in compliance with health authority regulations.
- Coordinating the complication of the non-clinical documentation for electronic submissions including tracking progress of document delivery, gathering metrics for submission processing, quality assurance, releasing, archiving in accordance with SOPs and guidance documents.
- Ensuring high overall submission quality.
- Providing quality checks of Module 4 for final submission.
- Liaising with concerned functions, regulatory product managers and external third-party organisations when applicable.
- Facilitating communication and collaborating to meet submission timelines and planning future work.
- Participating in project planning activities.
- Ensuring documents are compliant with Roche standards and FDA/ICH guidelines.
- Bookmarking and hyperlinking PDF documents to ensure adherence to guidelines for incorporation into eCTF submissions using PDF editing tools, including Adobe Acrobat Professional and ISI Toolbox.
- Supporting non-clinical scientists and external authors in preparing experimental reports and documents for archiving or in support of regulatory submissions.
- Assisting in the use of formatting tools, such as MS Word and Adobe Acrobat.
- Uploading eCTD compliant documents into the Roche document management system (RAPID) ensuring proper location and correct metadata entry for regulatory submissions.
- Submitting final reports to the Research Document Repository (RDR) and updating the non-clinical study tracking system (SafetyPlan).
- Advising non-clinical scientists on report publishing requirements and processes.
- Supporting process improvement, participating in working groups, and writing/updating relevant guidance.
Skills and Requirements:
- At least 1 year in a regulatory documentation environment, preferably in the pharma industry.
- Advanced technical skills with Adobe Acrobat, with experience with PitStop Pro and ISIToolbox plugins a desirable
- Advanced technical skills with Microsoft Word.
- Fluency in both oral and written English, especially for working in a collaborative environment.
- Excellent attention to detail and ability to stay focused on detail with large projects.
- An ability to work under time pressure and adapt to quickly changing priorities.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Andrea Rotmistrovsky on +44 03 854 0675 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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