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Medical Writer - QC and Submissions

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Work with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.

Responsibilities include helping in the preparation of regulatory documents in accordance with the ICH guidelines, international regulations, Company standards and processes, and the Company Writing Style Guide as applicable.

Documents include but are not limited to: Protocols and protocol amendments, clinical safety reports, narratives, and Investigator brochures.

Responsible for managing the document review process, routing documents for approval using an electronic document management system (eDMS), performing Quality Control (QC) checks, and compilation of CSR supporting documents and submission documents. The medical writer should be familiar with ICH guidelines, ISI writer templates, document management systems, and the current AMA Style Manual. The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines, and to work with the submission manager to compile and prepare documents for submission.

Qualifications:
Bachelor's degree in life sciences, RN, or Master's degree in life sciences.
Excellent QC, formatting and editing skills, meticulous attention to detail, prior experience of using programs like Visio, Power Point, proficiency using an eDMS and standard style guide.
Experience: 5+ years’ similar work experience in the pharmaceutical industry. Prior experience in oncology is a plus.

The most important requirement is the ability to write documents in collaboration with the various members of study team.

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