Senior Medical Writer
20 hours ago
Liverpool
Job Title: Senior Medical Writer, Clinical and Regulatory Department: Medical Writing Location: UK, Fully Remote Job Type: 12 Month Contract /FTC Remuneration: Up to £80,000 This 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 provided, • Represents MW at meetings, • Drives document development meetings, • Articulates document strategy and timelines, • Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss, • Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly, • Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development, • Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict, • May review the work of junior and outsourced MWs, • May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion, • Writes 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 audience, • May mentor junior staff, • Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area, • Remains compliant with internal training JOB REQUIREMENTS: Education • Minimum of 3 years of relevant MW experience including working knowledge of biostatistics., • Strong knowledge of the clinical research process and regulations/guidelines, • Clinical document reading, writing, and editing experience, • Strong organizational, interpersonal and communication skills, • Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems, • Ability to manage multiple projects, • Familiarity with ICH GCP guidelines For more information, please reach out to You MUST be UK based and hold the Full Right to Work