GENERAL SUMMARY OF DUTIES – This position will have the overall responsibility for researching, writing, and editing clinical reports, protocols, and other related documents in multiple therapeutic areas. The Medical Writer will work in conjunction with other SCRI Services Departments and Sponsors, as appropriate, for the effective preparation and timely delivery of contracted material.
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
• Research and review of literature, writing, and summarizing clinical data from studies for FDA submissions and for publication and/or presentations, ensuring timely delivery.
• Providing project management of writing-only projects.
• Responsibility for medical writing document version control.
• Research, writing, editing, and proof-reading clinical summaries, data, and reports.
• Maintaining consistency of style and developed formats, templates, content for IND submissions, and guidelines for clinical documentation in support of scientists.
• Preparation of Investigator’s Brochures and other documentation in support of clinical programs including study abstracts and regulatory documents.
• Assisting clinical and regulatory teams prepare and write phase I-IV clinical and regulatory documents such as clinical study protocols, study reports, FDA reports, etc.
• Preparation of clinical documents in accordance with templates, global standards, FDA, ICH, and GCP guidelines and in accordance with electronic publishing standards (when applicable).
• Providing on-going writing style checks for all clinical writing output.
• Completion of projects in accordance with internally established timelines.
• Training of incoming Medical Writers.
• Adhering to SCRI Services SOPs and applicable Guidance Documents.
• Participating in educational activities and programs.
• Maintaining strictest confidentiality.
• Performing related work as required.
KNOWLEDGE, SKILLS, & ABILITIES – This position requires the following minimal requirements:
• Thorough understanding of GCP, ICH guidelines and local regulations.
• Ability to work within deadlines.
• Excellent problem-solving, planning, analytical, and organizational skills.
• Strong verbal, written and interpersonal communication skills are essential.
• High level of proficiency with MS Office products, including Outlook, Word, and Excel.
• Bachelor’s degree or equivalent and/or training or equivalent combination of education and experience.
• Two to three years minimum of relevant medical writing experience or relevant clinical research experience.
• Two years experience as a CRA/Study Manager, compliance auditor, or a combination in healthcare, clinical research or other science-related field.
• Experience with preparation of clinical study-related documents and/or research publications desired; experience with regulatory documents and processes beneficial.
• Or equivalent experience