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Content writing • colorado springs co
Medical Writing Coordinator
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A company is looking for a Medical Writing Coordinator / Publisher II (Remote) to manage clinical and regulatory documentation.
Key Responsibilities
Format, publish, and coordinate Clinical Study Reports (CSR) Appendices and ensure compliance with regulatory standards
Maintain knowledge of regulatory information management systems (RIMS) and assist in the development of medical writing operations processes
Mentor and provide guidance to less experienced staff while tracking metrics and managing communication with stakeholders
Required Qualifications
A minimum of 4 years of relevant industry experience in medical writing within pharma, biotech, or life sciences
High School diploma required
Knowledge of clinical document organization, eCTD structure, and drug development processes
Detail-oriented with a commitment to delivering high-quality and compliant documentation
Ability to work independently and collaboratively in a team environment