Medical Writer
3 weeks ago
Medical Writer
Location: San Rafael, CA. (Hybrid)
7 month assignment (Potential to extend)
Pay Rate: $52/hr.
On behalf of our client a pharmaceutical company specializing in the development of therapeutics for patients dealing with rare genetic life threatening diseases. The Contract Medical Writer applies advanced expertise in document preparation and project management to support the development, drafting, review, and finalization of clinical study documents. These documents are critical for regulatory submissions and publications, ensuring the accurate reporting of clinical study results.
Main Responsibilities:
- Draft and edit documents for regulatory submissions, including Common Technical Documents (CTDs) and Responses to Questions (RtQs).
- Develop and refine documents used in clinical studies, such as protocols, protocol amendments, and informed consent forms.
- Prepare documents for reporting aggregate safety and efficacy data, including investigator brochures and periodic safety reports (e.g., PSURs, DSURs).
- Lead cross-functional study teams in document preparation activities.
- Organize and facilitate meetings to manage timelines, reviews, and the adjudication of comments.
- Ensure adherence to departmental procedures, industry standards, and regulatory guidelines.
- Partner with internal teams across Clinical Medical Writing, Biostatistics, Clinical Operations, Regulatory Affairs, Medical Affairs, and other departments to achieve project goals.
- Provide clear and effective communication to align cross-functional teams on documentation requirements and timelines.
Qualifications and Education:
- Bachelor’s degree in a scientific field and 5 +years of medical or scientific writing experience, preferably within the pharmaceutical industry.
- Familiarity with the drug development process, from discovery to market.
- Proven expertise in writing, reviewing, and editing clinical study documents, including protocols, clinical study reports, INDs, and BLA/NDAs.
- Advanced knowledge of content preparation standards, including style guides (AMA, CBE, Chicago Manual), medical dictionaries, and regulatory guidance documents.
- Proficient in interpreting and presenting clinical data using tables, graphs, and clinical laboratory tests.
- Basic understanding of coding dictionaries (MedDRA, WHO Drug) and biostatistical concepts.
- Previous experience with protocol development and clinical study reporting is highly desirable.
- Familiarity with regulatory requirements for standalone regulatory documents, such as investigator brochures and clinical study reports.
- Certification or relevant training in medical writing (e.g., AMWA, EMWA, Editor in Life Sciences) is a plus.
Please submit a copy of your resume in PDF or Word document to be considered
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