We have a current opportunity for a Senior Medical Writer on a permanent basis. For further information about this position please apply.
Senior Medical Writer
My client is a full-service CRO that provides an expansive range of expertise based clinical research services to worldwide biotechnology, pharmaceutical, and medical device industries as well as working with the most advanced biologics, drugs, and medical devices in development today. My client is well known in the industry for its high quality and on-time deliverables as well as their remarkable service to clinical research partners. This role will be 100% remote.
Senior Medical Writer:
My client is looking for a skilled Senior Medical Writer to deliver full-service medical writing, editing, and electronic publishing of regulatory documents and scientific publications. This fully remote role will act as a lead medical writer to the team where you will write clinical documents such as clinical study protocols, CSRs, statistical reports, integrated efficacy or safety summaries, patient narratives, manuscripts, posters, and abstracts. Please reach out for more information regarding the position.
- Work directly with Director of Medical Writing and Clinical Safety Monitoring to receive projects and project information such as (but not limited to) CSRs, protocols, previous publications, literature references, and Investigator's Brochures.
- Finalize documents for delivery to sponsors according to the established timelines.
- Peer review and QC for clinical documents developed by other Medical Writers.
- Act as primary contact between client and clinical trial sponsors for assigned projects.
- Provide accurate interpretation of study results based on the provided background materials and statistical analysis output.
Preferred Skills, Qualifications and Technical Proficiencies:
- Experience in multiple therapeutic areas and Phase I through IV clinical trials.
- Experience with client relationship management.
- Demonstrated experience, knowledge, and understanding of GCP/ICH guidelines, including E3 Structure and Content of Clinical Study Reports.
Preferred Education and Experience:
- Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences.
- Master's degree with substantial experience in the subject matter required.
- At least 6 years of medical writing practice.
Please reach out to Valentin Tenbrook for more information!