Job Description

Clario\xe2\x80\x99s medical imaging expertise is unparalleled to any other medical imaging core lab in the industry, and we\'re looking to hire an Associate Medical Writer to support multiple therapeutic areas to meet our documentation demands for new and existing clinical studies.

What we offer:

Competitive compensation

Attractive benefits (security, flexibility, support and well-being)

Engaging employee programs

Remote working & home office allowance

OTP Sz\xc3\xa9p Card

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 notifiying 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\xe2\x80\x99s Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.)

Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing

2+ years experience in pharmaceutical/clinical/imaging research preferred

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\xe2\x80\x99s only through our people that we can continue to innovate technology that will shape the future of clinical trials. Collaboration, Continuous Learning, Courageously Curious

Our appetite to blend the best of domain expertise, technology and human understanding knows no bounds. We\xe2\x80\x99re relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions.

Behaviors:

\xc2\xb7 We learn; embracing change, questioning how we work, finding a better way. And if it doesn\'t go to plan, we don\'t blame each other; instead, we own it and grow together
\xc2\xb7 We partner\' with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Critical Thinking, Deliver Exceptional

We step forward because responsibility powers us; we don\xe2\x80\x99t leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other.

Behaviors:

\xc2\xb7 We prioritize; focusing on what matters, never compromising on quality.
\xc2\xb7 We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., Organizational Awareness, People first, always

We think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patients\xe2\x80\x94and each other. We\xe2\x80\x99re united by our purpose\xe2\x80\x94it\xe2\x80\x99s why we go above and beyond to support each other, emphatically.

Behaviors:

\xc2\xb7 We do the right thing; for our customers, patients, sites and each other. And We\'re passionate about it.
\xc2\xb7 We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed., Results Orientation, Service Orientation

Clario