Closing Date: 10 Mar 17
Type: Full Time
Salary (£): Competitive
5 years experience Remote Excellent communcation skills FDA knowledge TA: Oncology/immunology PSUR CSR Protocols Clinical Submissions
Cytel are actively looking to recruit a Permanent Senior Regulatory Medical Writer to join our company.
The position can be remote and we are looking for a candidate with 5 years minimum experience and recent production of PSURs, CSR, Protocols, Clinical Submissions, ISS/ISE.
Summary of Job Responsibilities:
The Medical Writer independently prepares documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include, but are not limited to, clinical study reports, study protocols, investigator’s brochures, clinical summaries, briefing books and responses to authorities, abstracts and manuscripts.
Works with Project Manager to develop timelines and resource plans for the production of clinical study reports and filings to regulatory authorities.
Reviews statistical analysis plans, summary table shells, and case report forms as required.
Performs quality control (QC) review of clinical study reports, and clinical sections of regulatory submissions
Qualifications and Experience:
Minimum Education: BS/BSc/BA in a science or industry-related discipline.
Work Requirements: Minimum of 5 years of medical writing experience in a contract research organization (CRO), pharmaceutical, or biotech setting.
Skills: Working knowledge of ICH and other regulatory guidelines. Broad knowledge of global pharmaceutical regulatory requirements, and experience in clinical research or other areas of the pharmaceutical industry. The ability to accurately and clearly present clinical data as well as strong verbal and interpersonal communication skills. Fluency in English (spoken and written) is required. Excellent writing (e.g., English usage) and a keen attention to detail also are required. Proficiency in Microsoft Word and graphic presentations is required. A degree of experience in using e-submission systems.
ICC, Bat. C, 2nd floor, Route de Pré-Bois, 20 C.P. 1839, 1215 Geneva 15, Switzerland
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