DEPARTMENT: Medical Writing
REPORTS TO: Department Supervisor/Manager or Director
Assist in the coordination, organization, and prioritization of study tables as well as assist in the review of in-life data. This is an entry-level position with the expectations of supervised and/or semi-independent functionality, demonstrating a comfortable level of project coordinating and writing skills in the Medical Writers Department.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Assist in the quality control (QC) of in-life data in accordance with SOP, GLPs, and protocol standards. Also assist to ensure that the appropriate person(s) receive and make corrections to data before returning to Study Director and/or QA. Assist in meeting data submittal timelines through the coordination of data review.
- Participate in the general data overview during procedures as appropriate (ie, assisting in the in-life QC process of study records on a daily basis for compliance with SOPs and/or protocols).
- Assist in the assembly of in-life tables for reporting purposes as well as the final preparation of the study binder.
- Assist in the administrative tasks (i.e., back-up assistance in Test/Control Article log-in and study shipment process, scanning items for Study Directors and/or Medical Writers).
- Assist/coordinate Sponsor requests to aid Study Directors.
- Assist in interdepartmental collaboration; ensure effective communication, process improvement, and data flow/transitions.
- Organize CBSET and outside vendor paperwork.
- Assist in the coordination and relative responses to in-life QAIRs to ensure that the QAIRs are addressed in a timely manner.
- Assist in/communicate the updating of data timelines on PC Assignment Excel spreadsheet.
- Assist in the transfer of study books to DSU (Data Storage Unit) when final QC is complete and update data schedule accordingly.
- Perform other duties as assigned.
- The ability to multi-task, coordinate, prioritize, and implement change in combination with flexibility as well as excellent communication and writing skills is a must.
- Experience with Microsoft Office, word processing spreadsheets (Excel, etc.), and Adobe software.
- Industry-related pre-clinical data management skills experience preferred.
- Undergraduate degree in a related life sciences field preferred.
- Experience with Electronic Data Management System software in a lab setting preferred.
- Must be computer literate with a willingness to learn and adapt to various computer skills.
- Must pay attention to detail and constantly question the validity of data.
- Must be able to lift heavy books and sit and type for long periods of time.
- Animal facility and laboratories with moderate noise possible and exposure to hazardous/noxious devices (e.g., needles, scalpel blades etc.) and chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.)
- General office working conditions, with generally quiet noise conditions
All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
If you are interested in this opportunity please send your CV to firstname.lastname@example.org.