Specialist, Operations Associate
Location: Gaithersburg, MD
Duration: 6-month contract
Compensation: $33-38 per hour
As Operations Associate in Gaithersburg, MD, you'll play a pivotal role in channeling the company's scientific capabilities to make a positive impact on changing patients' lives.
As the Operations Associate, you will be part of Medical Writing Operations (MW Ops) and responsible for providing overall operational support in development, approval, and filing of clinical documents for regulatory submissions within the Medical Communications (MC) Department. You will work under general supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.
- Collaborate with Medical Writer on Clinical Study Report (CSR) production, including Section 14 and Appendix 16 document collection. Manage assembly and uploading to the electronic document management system (EDMS) and pre-publish CSR as per Medical Writing/MW Ops process.
- Perform PDF checks for Adobe Acrobat documents to meet submission-ready standards for global Health Authorities.
- Review and format diverse scope of documents in new House Style, MS Word, and perform document cleaning activities to meet submission-ready standards for global Health Authorities.
- Assist colleagues in document formatting troubleshooting for a diverse scope of documents in MS Word and Adobe Acrobat applications.
- Provide support with filing and QC of Trial Master File (TMF) and electronic TMF (eTMF)
- BA/BS degree or equivalent work experience in medical writing or regulatory submission field for pharmaceutical industry, academic institutions, and/or clinical research organizations.
- Knowledge of regulatory documentation, including CSR production and pre-publishing; formatting and PDF checks; and/or filing to TMF/eTMF, a plus.
- Proficiency in MS Office 2010 and Adobe Acrobat Professional
- Knowledge of ISIToolbox applications, and working in EDMS environment, a plus.
Sthree US is acting as an Employment Business in relation to this vacancy.