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Associate Medical Writer ( Remote)

1-2 years
Not Disclosed
10 Jan. 15, 2024
Job Description
Job Type: Full Time Education: BPharma Skills: Communication Skills, Interpersonal Skill, Technical Skill
  • 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