SUMMARY:
Provide technical and medical writing support for nonclinical testingincluding data assembly, and table, report and protocol preparation
ESSENTIAL DUTIES ANDRESPONSIBILITIES:
- Prepare and coordinate the development of protocols, reports, amendments and other non-clinical documents in accordance to SOPs and other guidance documents
- Create tables, graphs and data summaries
- Provide QC check of data and text against source documents
- Responsible for medical writing aspects of an assigned project and coordination, and adherence to timelines
- Ensure efficient formatting of documents including hyperlinking, and ensure a consistent style of presentation to maintain quality
· Create templates asneeded
- Contribute to medical writing initiatives to develop and improve processes
- Interact with Clients on documents
- Performs other duties as assigned by Management
QUALIFICATION REQUIREMENTS:
Toperform this job successfully, an individual must be able to perform eachessential duty satisfactorily. The requirements listed below are representativeof the knowledge, skill, and/or ability required.
EDUCATION and/or EXPERIENCE:
Collegedegree (Bachelor’s or Associate’s degree) with a minimum of two years relatedexperience; or equivalent combination of education and experience in theperformance of duties as described. Also require:
- Excellent written and verbal communication skills
- Extensive knowledge of English grammar with a familiarity with a standard style guide
- Ability to communicate scientific or medical information in a clear and concise manner
- Familiarity with scientific terminology
- Excellent organizational and time management ability
- Ability to prioritize and manage several projects simultaneously
COMPUTER SKILLS:
- In-depth knowledge of MS Word, Excel and ability to learn other programs quickly
LANGUAGE SKILLS:
Abilityto read and interpret documents such as operating instructions, and proceduremanuals. Ability to speak effectively and communicate well with managers,employees, and clients.
MATHEMATICAL SKILLS:
Abilityto add, subtract, multiply, and divide in all units of measure, using wholenumbers, common fractions, and decimals. Ability to compute rate, ratio, andpercent.
