Medical writer

• Lead planning and preparation of high-quality clinical regulatory documents
• Produce protocols, publications, study reports, investigator brochures, narratives, and module documents
• Lead document execution and project management tasks, including creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure document development follows client processes, templates, and instructional documents
• Serve as an expert on client document management systems, tools, templates, and procedures
• Lead document message development with clients
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate review feedback and comment resolution meetings
• Follow up with team members to resolve outstanding review feedback
• Ensure consistency in messaging, formatting, and presentation across client programs
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management

Senior Medical Writer

• Lead execution of clinical regulatory documents and related project management tasks, including creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure document development follows client processes, templates, and instructional documents
• Serve as an expert on client document management systems, tools, templates, and procedures
• Lead document message development with clients
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate review-feedback resolution, including planning and leading comment resolution meetings
• Follow up with team members to resolve outstanding review feedback
• Ensure consistency in messaging, formatting, and presentation across client programs
• Conduct literature searches as needed
• Perform peer QC reviews as needed
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management

• Lead execution of clinical regulatory documents and related project management tasks
• Create, maintain, and communicate project timelines
• Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure documents follow client processes, templates, and instructional documents
• Serve as an expert on client document management systems, tools, templates, and procedures
• Lead document message development with clients
• Interpret data and create shell documents for authoring
• Plan and lead kickoff meetings
• Facilitate review-feedback resolution and lead comment resolution meetings
• Follow up with team members to resolve outstanding review feedback
• Ensure consistency in messaging, formatting, and document presentation across client programs
• Conduct literature searches as needed
• Perform peer QC reviews as needed
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management

• Research, write, and edit manuscripts, abstracts, slide presentations, posters, and other deliverables
• Collaborate on highly visible client projects involving pharmaceutical products and medical technologies
• Review study data and distill it into thorough, well-written deliverables
• Communicate with team members to achieve content development goals
• Deliver work by designated deadlines and understand the project development process
• Work collaboratively in onsite and remote team environments
• Ask supervisors for assistance when appropriate
• Save all deliverable versions to team files using standardized file-naming criteria
• Work respectfully and productively with the internal team

Medical Writer – Publications

• Develop content outlines and drafts under close supervision and guidance, including slide decks, digital materials, manuscripts and congress publications, and meeting materials
• Produce well-researched, technically accurate, well-written, and presentable materials
• Adapt writing and communication style to the relevant target audience
• Ensure materials meet project briefs, specified time allowances, and in-house quality standards
• Volunteer proactively for accurate data checking in line with BOLD processes
• Develop visual PowerPoint presentations
• Incorporate feedback accurately and carry it forward into future work
• Develop scientific knowledge of therapy areas and client accounts through proactive research, including reading scientific articles
• Learn about the Medical Communications industry, healthcare community, BOLDSCIENCE processes, and pharmaceutical industry processes
• Learn the internal quality control process, including internal reviews
• Support delivery of high-quality scientific content
• Manage and prioritize time across different projects
• Contribute to internal status calls and keep the team updated on actions
• Use initiative to solve problems and drive results, seeking senior support when required
• Collaborate with client services, creative, and the wider BOLD team
• Meet deadlines and communicate progress or delays to senior scientific team members
• Complete timesheets accurately and promptly
• Maintain an average billability of 85–90%

Associate Medical Writer

• Develop value communication materials, including value and reimbursement dossiers, value stories and objection handlers, scientific reports, publications, abstracts, posters, manuscripts, and presentation/slide deck content
• Take ownership of assigned project deliverables from development through completion
• Synthesise and interpret scientific, clinical, and health economic evidence
• Ensure content is accurate, evidence-based, and aligned with client needs
• Participate in client meetings and contribute to scientific discussions
• Build strong working relationships with colleagues and clients
• Contribute to a culture of continuous learning, quality, and innovation

Medical Writer

• Acts as Lead Medical Writer on most types of writing projects
• Prepares assigned documents according to IQVIA SOPs, customer requirements, and agreed timelines
• Performs Senior Review of straightforward medical writing deliverables
• Negotiates timelines and discusses/resolves customer comments
• Provides written and verbal feedback to junior staff and customers when appropriate
• Keeps current with medical, technical writing, regulatory knowledge, and GCP developments
• Leads preparation of assigned documents, confirms scope, templates, specifications, timelines, reviews, and customer communication
• Plans and organizes workload, tracks timelines, and implements customer requests
• Leads meetings on challenging topics
• Presents Medical Writing processes at bid defense meetings
• Assists with training and development of junior staff and may deliver global team training
• May act as Project Manager for complex Medical Writing projects, including finance and invoicing responsibilities
• Completes project finance activities, including monitoring and forecasting budgeted hours
• Proposes, reviews, and approves routine project budgets and costings
• May take on customer lead responsibilities or assist partnership leads
• May represent the region or site on Medical Writing and cross-functional initiatives
• Facilitates identification of new ideas and may represent Medical Writing at capabilities audits

Principal Medical Writer

• Independently plan and prepare regulatory documents and medical communications supporting all phases of product development
• Organize, analyze, interpret, and present scientific and statistical information
• Ensure documents comply with ICH, other regulatory guidelines, and company document standards
• Work under the direction of Medical Writing management
• Collaborate with cross-functional internal and external document production teams

• Independently plan and prepare a range of regulatory documents and medical communications supporting all phases of product development.
• Organize, analyze, interpret, and present scientific and statistical information in accordance with ICH and other regulatory guidelines and company document standards.
• Work under the direction of Medical Writing management.
• Collaborate with cross-functional internal and external document production teams.

• Lead clear and accurate medical writing deliverables and manage writing activities across departments
• Lead resolution of client comments
• Complete protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and act as a peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and resolve issues, escalating as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standard practices, and capabilities
• Mentor and lead less experienced medical writers
• Develop expertise in industry topics and regulatory requirements
• Monitor assigned project budgets and communicate status and changes to medical writing leadership
• Complete administrative tasks and other assigned duties
• Minimal travel may be required, less than 25%

Medical writer jobs in United Kingdom

Senior Medical Writer

Senior Medical Writer

Senior Medical Writer

Medical Writer – Publications

Associate Medical Writer

Medical Writer

Principal Medical Writer

Senior Medical Writer

Principal Medical Writer

Senior Medical Writer – Regulatory Focus