Job Description

This will be for an associate medical writer to be trained on and work on certain tasks within the imaging division.Are you looking to kickstart a purposeful and rewarding Medical Writing career?Our Oncology Medical Writing team is growing in India, and with big ambitions and a clear vision for the future, now is the time to join Clario as an Associate Medical Writer.What we offer:Competitive compensationAttractive benefits (security, flexibility, support and well-being)Engaging employee programsTechnology for hybrid working and great onsite facilitiesWhat you'll be doingPerforms 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 TeamsPerforming 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 labelsCreating, 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 MinutesAttending internal and external meetings relating to the Site Manuals, CRs and any other MedComm-related study start-up documentsCreating, 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 webpagesPerforming Project Close-outs as they occur based on receipt of Project Closeout RequestsReviewing, 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 CRsUpdating, modifying and maintaining the MedComm database and applicable document tracking spreadsheets to track document progress and study detailsProviding guidance to assigned Project Teams and Project Team membersProviding language updates, as required, for all MedComm document templates as neededCreating Final Effective documentsMaintains 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 processesParticipating 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 modulesAttending and participating in applicable company-sponsored trainingWhat we look forBachelors Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferredExperience:1+ years medical writing experience preferred, but is not required.2+ years 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 desiredAbility 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 concurrentlyAt Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. Its only through our people that we can continue to innovate technology that will shape the future of clinical trials.These positions are subject to European and US working hour shift patterns, and are considered hybrid remote working roles from our offices in VG Heritage, 18/2, 18/3, Vani Vilas Road, Basavanagudi, Bangalore 560004