Associate Medical Writer

Company: BioClinica
Location: Neeses
Posted on: September 24, 2022

Job Description:

Primary Responsibilities

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

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
Participating 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
Attending and participating in applicable company-sponsored training

Qualifications

Education:

Bachelor's Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferred
Experience:
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

Additional Skill Set:

Ability to work in a group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude
Organization and time management skills for managing multiple projects concurrently

Working Conditions

Travel: 0-5%

Lifting: 0-10lbs

Other: Computer work for long periods of time

This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.

EEO Statement

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

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