Company DescriptionBioclinica 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 organizationsJob DescriptionThe 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 ResponsibilitiesPerforms study start up responsibilities by:Creating, modifying and finalizing Site Manuals, associated fillable forms, Quick Reference Guides and labelsCreating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) SummariesCreating, modifying and finalizing Quality Control (QC) SummariesCreating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Notes to File (NTFs), Corrections and Deviation ReportsCreating, modifying, and finalizing Key Points Documents (KPDs) from CRsCreating, modifying and finalizing paper Source Documents based on ToOsCreating, reviewing, modifying and finalizing MedComm Meeting MinutesAttending 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 documentsRunning Scheduled Tasks for generating MedComm webpagesMaintaining MedComm document webpagesChecking MedComm webpages for errorsPerforming Project Close-outs as they occur based on receipt of Study Closure formsReviewing and updating Charter Training Slides (CTS) and CTS quiz(zes) as neededDocumenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, etc.) by filling out and collecting signatures on group training forms as requiredManages 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 CRsUpdating the MedComm database every time a document is created, sent out for internal or Sponsor review, finalized, deemed inactive/on-hold, or cancelledProviding guidance to assigned Project Teams and Project Team membersProviding language updates, as required, for all MedComm document templates as neededCreating Final Effective documentsSecondary ResponsibilitiesMaintains Quality Service and Departmental Standards by:Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)Updating department SOPs and Work Instructions as neededAssisting in establishing and enforcing departmental standardsContributes to team effort by:Working with internal staff to resolve issuesExploring new opportunities to add value to organization and departmental processesParticipate in internal training activitiesHelping others to achieve resultsPerforming other duties as assignedMaintains Technical and Industry Knowledge by:Staying up-to-date on response criteria publications posted by Medical CommunicationsParticipating in Medical Writing Training activities, including creating/reviewing training modulesParticipating in Clinical Project Management Training activities, including creating/reviewing training modulesAttending and participating in applicable company-sponsored trainingQualificationsEducation:Bachelor’s Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferredExperience:1 years medical writing experience required2 years of experience in pharmaceutical/clinical/imaging research preferredDemonstrated proficiency in medical, pharmaceutical, regulatory, clinical writingProficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access)Understanding and knowledge of medical and/or clinical trial terminology desiredAdditional skill set:Ability to work in a group setting and independently; ability to adjust to changing prioritiesExcellent attention to detail and orientation toward meticulous workStrong interpersonal and communication skills, both verbal and writtenStrong documentation and organizational skillsAbility to project and maintain a professional and positive attitudeOrganization and time management skills for managing multiple projects concurrentlyAdditional InformationWorking conditions:Travel: 0-5%Lifting: 0-10lbsOther: Computer work for long periods of time EEO StatementBioclinica 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