Job Title: Senior Medical Writer, Clinical and RegulatoryDepartment: Medical WritingLocation: UK, Fully RemoteJob Type: 12 Month Contract /FTCRemuneration: Up to £80,000This is a 12-month contract role, and you MUST be able to start this role within 4 weeks.The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided.The SMW tracks his/her own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion.JOB RESPONSIBILITIES:Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be providedRepresents MW at meetingsDrives document development meetingsArticulates document strategy and timelinesIdentifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fussFollows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quicklyParticipates in process improvement initiatives, working groups, etc. within MW and throughout Global DevelopmentManages processes and organizes priorities; solves problems; fosters collaboration to resolves conflictMay review the work of junior and outsourced MWsMay review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusionWrites in plain language style as appropriate (eg, for ICFs)Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audienceMay mentor junior staffEnsures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic areaRemains compliant with internal trainingJOB REQUIREMENTS:EducationBachelor's degree (advanced degree preferred)ExperienceMinimum of 3 years of relevant MW experience including working knowledge of biostatistics.Strong knowledge of the clinical research process and regulations/guidelinesClinical document reading, writing, and editing experienceStrong organizational, interpersonal and communication skillsStrong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systemsAbility to manage multiple projectsFamiliarity with ICH GCP guidelinesFor more information, please reach out to lucy.kirkaldy@You MUST be UK based and hold the Full Right to Work
Job Title
Senior Medical Writer