Location: Remote
Duration: 6 months temp to perm
Job Description:
A Black Diamond client is looking for a Sr. Clinical Medical Writer for a Sr. Manager level role. This individual will be responsible for writing and overseeing the writing of various clinical and regulatory documents. This is an independent contributor position.
Responsibilities:
- Write, edit, or collaborate on development of clinical and regulatory documents (protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
- Ensure smooth and effective document management from start to finish (i.e., from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing and managing various processes (Reviews, QC, QA, formatting, publishing, document archiving)
- Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards
- Distill large amounts of clinical and scientific data into essential elements for graphical display
- Oversee document review and comment resolution meetings with cross-functional teams
- Formulate key messages from clinical study data
- Perform literature-based research to support writing activities
Requirements:
- PhD in a scientific or medical field highly preferred
- 5+ years in the biotechnology/pharmaceutical industry in addition to education
- Rare disease experience and a strong understanding of metabolic genetics and gene therapy a plus
- Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs
- Familiar with eCTD structure, and experience with eCTD summary documents (Modules 2.5 and 2.7) and regulatory briefing documents
- Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design. Projects and Visio a plus
JOB ID# 227163
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