Medical Writer - Part-Time

CPL

Dublin West

Our client, a global pharmaceutical company, are currently recruiting for a Medical Writer.This is a part-time role, 3 day week. Establish a central point of contact for all medical writing projects, liaising with other Group departments as the need arises. Undertake all research, creation, and editing of all documents to comply with safety and clinical updates according to the Global Company Core Datasheet (CCDS) for all Products. Develop a framework for setting internal and external deliverables against each medical writing project, to include project goals and objectives and measurement criteria and business outcomes for each project goal. Conduct leadership, training and support of junior medical writing staff. Resoponsibilities: Financial : Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective. Identification of project challenges to departmental line management and the financial impact thereof. Project Management: Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects to be performed with management where necessary. Serve as the Medical Writing representative to provide proactive support for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Group guidelines/SOPs. Coordinate production and distribution of draft and final documents to regulatory teams. Ensure that all work is complete and of high quality prior to team distribution. Attend internal and technical team meetings as required. Assist management as needed with preparation of resourcing estimates for potential new medical writing projects. Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner. Medical Writing Accountabilities: Write clinical documents for submission to regulatory authorities, including but not limited to: clinical overviews and summaries. clinical expert statements. interim and final clinical study reports. integrated summaries of safety and efficacy. nonclinical overviews and summaries, where applicable. Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review. Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate SOPs and style guidelines. Perform literature searches/reviews as necessary to obtain background information and training for development of documents. Prepare country specific packs for submission of safety variations within CA, EU, US and other territories as needed. Assist in the assessment of clinical and nonclinical documentation with regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications. Adherence to Company Health & Safety procedures Participate in training programmes. Any other duties as assigned by your Manager. Safety: Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports. Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans Manage safety related requests from regulatory agencies and company Affiliates to ensure any requests are answered fully and promptly. Training: Provide training and guidance and act as a mentor to less experienced departmental members. Initiate and participate in departmental or interdepartmental process improvement and training initiatives. Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs/WINs. Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department. Miscellaneous: Maintain rigorous adherence to written procedures, e.g. SOPs/WINs. Adherence to Company Health & Safety procedures Participate in training programmes. Any other duties as assigned by your Manager. Requirements. Previous experience within a similar role. Results and performance driven – deliver results that meet or exceed expectations. Sense of urgency – responding to issues and opportunities in a timely manner. Intellectual curiosity – willing to suggest and try new ideas. Positive and pro-active approach to business tasks. Excellent interpersonal and communication skills. A solutions provider with strong multi-tasking abilities. Manage evolving deadlines effectively with regular feedback and updates. Enthusiasm and Drive to take ownership and drive process initiatives. This job originally appeared on RecruitIreland.com.

1968 days ago