Crown CRO Oy is looking for a Medical Writing Document Manager to work as an insourced employee for a pharmaceutical company in redaction and anonymization activities of clinical research documents. The clinical documents prepared by the company’s Medical Writing group and clinical teams are required by certain Health Authorities to be posted in public domain in either a redacted or anonymized format and the Medical Writing group coordinates these activities.
Medical Writing Document Manager will support all medical writing functions in the following areas:
- Project management of anonymization/redaction activities, including:
- Coordinates the redaction/anonymization activities for personal data in clinical documents according to applicable guidelines and local laws as well as ensures timely delivery of anonymization reports when applicable
- Interfacing with the company’s study teams, regulatory (local and global), legal, and other stakeholders on acceptable anonymization criteria
- Participates to the development and maintenance of the commercial confidential information (CCI) strategy, coordinates the CCI redactions and leads the preparation of justification documents as needed
- Organizes a kick-off meeting for a clinical data transparency submission and trains relevant functions on the processes and guidelines
- Manages the vendor interactions for the data redactions/anonymization and have an oversight of deliverables
- Ensures all deliverables are provided according to set timelines and with excellent quality
- Interfaces with Health Authorities in collaboration with the company’s regulatory, as needed (e.g. Health Canada PRCI PIM Meeting)
- Develop process of handling and managing Health Canada PRCI and EMA Policy 70 requests.
- Assist in internal process documentation preparation such as SOPs/OIs, guidance documents, etc. when needed
- Manage any overflow of redaction projects, as needed
- Trains new colleagues as needed
Bachelor’s degree or equivalent with at least 5-7 years of experience the pharmaceutical industry in total, with demonstrated regulatory or clinical experience. Knowledge of various clinical study documents required by country authorities for redaction and/or anonymization. Knowledge of various health authority redaction and anonymization requirements and guidance.
Skill & Competency Requirements:
- Strong communication skills, both written and verbal required to articulate concepts and ideas.
- Previous experience in project management
- Comfortable in interacting with people in all hierarchy levels
- Global working experience
- Excellent electronic document management and IT skills
- Ability to work efficiently, precisely and independently
- Previous vendor management experience
- Experience in working for EMA Policy 70 or Health Canada PRCI submissions is preferred
Interested? Please introduce yourself by sending an application and CV with salary expectation by 31 Oct 2021 to email@example.com
For additional information, please contact Chief Commercial Officer Kaius Heinilä, +358 40 516 4785 on 13 Oct and 26 Oct at 12:00-13:00 (UTC+2).
Crown CRO is a private company with Finnish roots and a global network. Since 2005 we have been operating in clinical studies. We specialize in customer-oriented, competitive, and flexible services for clinical trials and regulatory affairs in Europe and the United States, serving the pharmaceutical, biotech, functional food, and medical device industries as well as contract research organizations. In addition to CRO services, we provide medical language services to our customers. Our headquarters is located in Espoo, Finland and we have strong presence in Sweden, Denmark, Norway, Estonia, Latvia, and Lithuania. www.crowncro.com