Senior Documentation Specialist
7 hours ago
High-quality clinical and safety documentation is crucial for regulatory authorities to approve marketing applications. As a Regulatory Medical Writer, you will be responsible for creating and reviewing such documents.
Key Responsibilities- Create high-quality clinical and safety documents, including non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP).
- Lead outsourced Narrative projects and coordinate other outsourced activities in RWS.
- Collaborate with cross-functional teams, including the Clinical Trial Team (CTT) and Safety Management Team (SMT), to ensure compliance with internal standards and external regulatory guidelines.
- Act as a documentation consultant to provide expertise on medical writing and document consistency.
- Bachelor's degree in life sciences or equivalent.
- Advanced degree preferred.
- Experience in medical writing or relevant pharma industry experience with scientific and regulatory knowledge.
- Familiarity with global regulatory environment and processes.
The successful candidate will have strong scientific and regulatory knowledge, excellent communication skills, and the ability to work in a matrix environment.
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Documentation Specialist
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Quality Documentation Controller
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Dublin, Dublin City, Ireland Ipsen Full timeJoin to apply for the Quality Documentation Controller role at IpsenJoin to apply for the Quality Documentation Controller role at IpsenWHAT - Summary & Purpose Of The PositionThe Quality Document Controller is responsible for supporting the documentation requirements of the Quality department at IMIL and performing Document management activities in the...
