Job Title: Medical Writer
FLSA Status: Exempt
Job Number: 04500608
Department: Clinical Development
Description:
The Medical Writer will be a member of an inter-disciplinary project team, and be responsible for reviewing and preparing clinical/regulatory documents to support all phases of clinical drug development.
Essential Duties and Responsibilities:
- Prepare, edit, and review study protocols, investigator brochures, regulatory submissions, and integrated clinical/statistical reports;
- Work with CROs to develop and refine protocols, analysis plans and clinical study reports;
- Collaborate with internal project teams made up of clinicians, CRAs, biostatisticians, toxicologists, and pharmacokineticists; on the development and/or revision of clinical documents;
- Maintain timelines and workflow for document generation, revision, and completion between consultants, reviewers, and departments;
- Review/edit documents for organization, clarity, grammar, language, and scientific standards; resolve errors and inconsistencies in clinical data with other project team members;
- Perform editorial functions and quality control (QC) check of clinical submission documents;
- Ensure accuracy to source data and compliance with regulatory reporting requirements;
Job Requirements:
Education: Bachelor's degree or higher in scientific or clinical discipline.
Experience: 2 years relevant work experience in a pharmaceutical, biotech, or CRO environment.
Specific Skills: Strong verbal and written communications skills and strong interpersonal skills are essential.
Supervisory Responsibilities: None
Physical Demands/Work Environment: The job duties will require extensive word processing using computer and keyboard, and reading from computer monitor screen for several hours per day. Sitting for extended periods will be required to accomplish the writing and editing tasks. Physical labor will not be required; lifting will be limited to items no heavier than reams of paper. Attendance at team meetings will require walking between buildings, representing distances of ~1/8 mile or less.
