Senior Medical Writer

1 day ago


United Kingdom Cpl Life Sciences Full time

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 Bachelor's degree (advanced degree preferred) Experience 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 lucy.kirkaldy@cpl.com You MUST be UK based and hold the Full Right to Work



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