Associate Medical Writer

Clario

Remote, United Kingdom

At the forefront of clinical research innovation, our esteemed medical imaging core lab is searching for an Associate Medical Writer who 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 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.

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