Seqirus - Medical Writer
Built on 100 years of experience in influenza, Seqirus is a new global company with an exciting future. It was created in 2015 when parent company CSL Limited acquired the Novartis Influenza Vaccine business and combined it with its own longstanding influenza vaccine operations.
Seqirus is currently the world’s second largest influenza vaccine company and a major partner in the prevention and control of influenza globally. It is a reliable supplier of influenza vaccine for Northern and Southern Hemisphere markets and a transcontinental partner in pandemic preparedness and response.
We are currently looking for the. The position will be a key member of cross-functional clinical project teams and will report to the Head of Medical Writing & Disclosures. The incumbent will be responsible for planning, completing, managing and coordinating medical writing projects for Clinical Development. He / she will mitigate risk associated with medical writing and disclosure processes by participating in the development and maintenance of medical writing, disclosure and publication planning SOPs and Best Practices. The role holder will be responsible for contributing to the creation and maintenance of document and presentation templates, and will be responsible for the assembly and quality control review of medical writing projects for Clinical Development.
In terms of the location we are flexible - the position can be based in our office in Amsterdam (Netherlands), company headquarters in Maidenhead (UK), R&D Research Centre in Cambridge, MA or commercial office in Summit, NJ.
• Develop medical writing project timelines and plans.
• Coordinate and manages the tasks, roles, responsibilities and timing of the authoring team and internal / external reviewers to drive the process of document preparation and completion.
• Responsible for ensuring that the process and tools are used for comment resolution editing, formatting, quality checking and publishing in accordance with company SOPs, GCP and applicable guidelines.
• Identify risks to project goals and take appropriate mitigation and escalation steps to ensure that the authoring and review team stay on track with respect to timelines and quality.
• Coordinate the review, QC and assembly of medical writing deliverables.
• Facilitate QA, document finalisation, approval and electronic publishing.
• Participate in the development of medical-writing related Best Practices, SOPs, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
• Participate in creation and implementation of document templates and associated guidance tools (e.g., formatting, style and program-specific guides), that teams to author quality documents that meet appropriate corporate, industry, regulatory (FDA, EMEA) and international (GPP, GCP) guidelines and requirements.
• Elicit input from global stakeholders (e.g., CD, Regulatory, Project Management). Create templates, lead cross-functional, global stakeholder review teams; facilitate issue resolution; obtain approval of templates.
• Engage in implementation, adherence to and maintenance of guidelines, standards and templates through interactions with key stakeholders (e.g., Shared Services).
• Contribute to continuous improvement of existing processes and the creation of new processes, guidelines, standards and templates.
• Collect metrics and meet agreed targets for Key Performance Indicators.
• Ensure in-house / external resource is assigned to provide the medical writing deliverables required by the project team and in line with achievement of company objectives.
• Provide input into the strategy for medical writing vendor selection, define the scope of work to be outsourced and is responsible for medical writing vendor management. Develop and maintain medical writing vendor relationships where required. Participate in bid defence, contract development, work alignment and / or operation meetings.
• Negotiate with partner to determine roles, responsibilities, processes and mutual expectations.
• Cultivate an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
• Responsible for continual improvement of in-house medical writing.
• Provide expert medical writing support to other CD and Seqirus groups where required.