Matt Kitson Email & Phone Number

Cambridge, Uk

Line management, oversight of professional development, resource management and planning and overall performance review of internal team of writers.Lead Medical Writer responsible for planning, coordinating and writing of regulatory clinical documents required for submission dossiers seeking marketing approval and established medical products. Overseeing and coordinating multiple medical writers, QC specialists, and repository specialists for all activities involved in performing their projects. Advising clients on the writing and planning of complex projects.

Providing writing and consulting service to clients as an integral part of clinical development teams with worldwide pharmaceutical companies. Assisting teams in writing and coordinating successful documentation across a broad spectrum of therapeutic areas for regulatory submission packages.

Cambridge, United Kingdom

Providing writing and consulting service to clients as an integral part of clinical development teams with worldwide pharmaceutical companies. Assisting teams in writing and coordinating successful documentation across a broad spectrum of therapeutic areas for regulatory submission packages.

Preparation of key study-related documents (protocols, CSRs etc.), working with study teams to provide medical writing process guidance and support, providing expert advice and guidance to medical writing team and study team, working independently with sponsor teams to deliver projects, assisting in QC/review process, setting priorities for writing tasks, providing input on project requirements to project management, coordinating and communicating study start-up plans, working with study team to monitor study progress within medical writing scope.

Researching, writing, creating and coordinating clinical and regulatory documents for submission to regulatory authorities; providing support and expertise for more complex documentation; working with study management team to ensure timely and efficient delivery of documents; acting as primary contact with client; providing line-management, support and training to other medical writers; participating in project teams to deliver documents on time.

Available for freelance, long- and short-term contracting and consultant medical writing.Preparation of clinical study reports, SAE and AE narratives, global value dossiers and other clinical and regulatory writing projects.

Formerly Origin Pharmaceuticals/Constella Group.Sole European Medical Writer in charge of preparation of CSRs, protocols, IBs, PIPs, manuscripts, narratives, ICFs, IND/NDA/CTD/ISS/ISE, Clinical Overviews and others in a Global Contract Research Organisation.

Preparing clinical and regulatory documentation for early Phase I/II and first entry clinical trials.Developing investigator brochures, protocols, full clinical study reports and abbreviated study reports and synopses.Interacting with clinical study team to provide documentation to tight timelines in accordance with company policies and guidelines.Planning, scheduling and tracking of projects including support and coordination of project team.

Developing and maintaining web-based knowledge management system used by staff and volunteer organisations to share and exchange information nationwide.Researching, writing and editing health news stories and newsletter articles of interest locally and nationally.Promoting system to members of the public, by means of appropriate face-to-face training methods and ongoing support.Working with volunteers to improve healthcare at local, regional and national levels.Preparing guidance documents for use of system within patient and public involvement network.Point of contact and expertise for over 500 system users across six counties in East of England.

Researching and writing integrated Phase I-IV clinical/statistical reports to ICH guidelines.Writing pre-clinical, clinical and scientific reports, investigator’s brochures, expert reports, clinical and safety summaries, protocols, patient information and informed consent forms, integrated summaries of safety/efficacy, abstracts and papers.Ghost-writing articles for journal publication.Preparing bid documents, management of deliverable timescales and workload to allow completion of deliverables.On-site client support and training.

Handling of Global Adverse Event data reported in relation to all company products. Preparing narratives and support in preparation of PSURs etc.Preparing internal training and system documentation, SOPs, reports, project-specific guidelines and training packages and other business-related documents as required.Providing internal training on specialist areas and ongoing training and support of staff.

Researching, writing and editing of medical educational materials including product monographs, newsletters, patient information leaflets, physician training packs and journal supplements as well as multi-media education packs and direct-to-patient marketing materials for several major drug companies.Working with client companies and freelance writers and editors to prepare copy. Editing and re-writing copy prior to client approval. Liaison with client and designers to finalise high-quality art-worked product.

Abstracting and editing patent information received from World, European and National patent offices.Preparation and publication of weekly multimedia, “fast-alert” pharmaceutical and scientific information journals.Translating scientific German and French into English language articles.