The Medical Writer will be responsible for the creation and development of all study start-up documents such as the Site Manual and associated forms, as well any required Protocol Amendment Impact forms and Compliance Reports for the life of each study. The Medical Writer is also expected to provide guidance and support to the Clinical Project Management Team, including the review of Project-Specific Work Instructions and attending document-related Sponsor calls.

Primary Responsibilities

Performs study start up responsibilities by:

Creating, modifying and finalizing Site Manuals, associated fillable forms, Quick Reference Guides and labels
Creating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) Summaries
Creating, modifying and finalizing Quality Control (QC) Summaries
Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Notes to File (NTFs), Corrections and Deviation Reports
Creating, modifying and finalizing Key Points Documents (KPDs) from CRs
Creating, modifying and finalizing paper Source Documents based on ToOs
Creating, reviewing, modifying and finalizing MedComm Meeting Minutes
Attending internal and external meetings relating to the Site Manuals, IQA/PQA/QC Summaries, CRs/KPDs, Source Documents and any other MedComm-related study start-up documents
Running Scheduled Tasks for generating MedComm webpages
Maintaining MedComm document webpages
Checking MedComm webpages for errors
Performing Project Close-outs as they occur based on receipt of Study Closure forms
Reviewing and updating Charter Training Slides (CTS) and CTS quiz(zes) as needed
Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, etc.) by filling out and collecting signatures on group training forms as required

Manages the clinical study document development process by:

Creating, modifying, finalizing and attaching signed final Compliance Reports (CRs) to Final MedComm documents or review Project Team-created CRs
Updating the MedComm database every time a document is created, sent out for internal or Sponsor review, finalized, deemed inactive/on-hold, or cancelled
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

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by:

Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
Updating department SOPs and Work Instructions as needed
Assisting in establishing and enforcing departmental standards

Contributes to team effort by:

Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Participate in internal training activities
Helping others to achieve results
Performing other duties as assigned

Maintains Technical and Industry Knowledge by:

Staying up-to-date on response criteria publications posted by Medical Communications
Participating in Medical Writing Training activities, including creating/reviewing training modules
Participating in Clinical Project Management Training activities, including creating/reviewing training modules
Attending and participating in applicable company-sponsored training

Associate Medical Writer