At the forefront ofclinical research innovation, our esteemed medical imaging core lab is searching for anAssociate Medical Writerwho embodies precision, passion, and a penchant for progress. Your role will be pivotal in shaping the narrative of clinical trials, ensuring the integrity and clarity of medical communications, and ultimately, influencing the lives of patients worldwide.
What we offer
Competitive compensation
Attractive benefits (security, flexibility, support and well-being)
Remote working with full technology setup
What you'll be doing
Performs study start up responsibilities by:
Performing new award tasks such as entering new studies into the MedComm database, creating Medical Affairs and Medical Communications study-specific folders, organizing study documents, requesting signed Protocols, entering document costs in the new award spreadsheet, and notifying assigned Project Teams
Performing a concise and thorough review of study Protocols related to imaging requirements, schedules and windows.
Creating, modifying and finalizing Site Manuals, associated fillable forms, and labels
Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Protocol Amendment Impact Forms (PAIFs), Notes to File (NTFs), Corrections, non-Quality Event Deviation Reports, and Transfers of Obligation (ToO) as required/applicable.
Creating, modifying and finalizing paper Source Documents/eCRFs for reads performed outside a standard application (e.g., based on ToOs) on an as-needed basis.
Creating, reviewing, modifying and finalizing MedComm Meeting Minutes
Attending internal and external meetings relating to the Site Manuals, CRs and any other MedComm-related study start-up documents
Creating, updating and modifying the MedComm web pages for ease of access by IO, CPM, MA and any other departments who use the web pages. This includes running the Scheduled Tasks for generating the webpages
Performing Project Close-outs as they occur based on receipt of Project Closeout Requests
Reviewing, modifying and developing Standard Operating Procedures (SOPs)/Work Instructions pertinent to Medical Communications (and Medical Affairs, as applicable).
Updating MW training modules, as required.
Assist in the review and updating of the Reader Training Package (i.e., Charter Training Slides [CTS] and CTS quiz[zes]), when requested.
Manages the clinical study document development process by:
Creating, modifying, finalizing and attaching signed final CRs to Final MedComm documents or reviewing Project Team-created CRs
Updating, modifying and maintaining the MedComm database and applicable document tracking spreadsheets to track document progress and study details
Providing guidance to assigned Project Teams and Project Team members
Providing language updates, as required, for all MedComm document templates as needed
Creating Final Effective documents
What we look for
Bachelor’s Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferred
1+ years medical writing experience preferred, but is not required.
2+ years experience in pharmaceutical/clinical/imaging research preferred
Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing
Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access)
Understanding and knowledge of medical and/or clinical trial terminology desired
At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.
Clario is committed to providing an inclusive workplace that welcomes diversity and equal opportunity. We encourage all qualified candidates who are passionate about sustainability, ethical business, and making a positive impact to apply for this role.
United Kingdom
