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
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica 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