Associate Medical Writer

Company Description

Bioclinica is one of the leading global CRO company which focuses on bringing efficiency to the clinical trials. We have a premier global research network—and the only one with investigator sites in the U.S., Europe, Latin America, and Asia. We are headquartered in Doylestown, PA. Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. We serve more than 400 pharmaceutical, biotechnology, and device organizations

Job Description

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

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 required
• 2+ years of 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

Additional Information

Working conditions:

• Travel:  0-5%
• Lifting:  0-10lbs
• Other:  Computer work for long periods of time