Principal Medical Writer II

The Principal Medical Writer is a key member of cross-functional clinical project teams.
The incumbent will be responsible for planning, preparing, managing and coordinating medical writing projects for Clinical Development within R&D.
They will mitigate risk associated with medical writing and disclosure processes by participating in the development and maintenance of medical writing and publication planning SOPs and Best Practices.

Responsibilities include:
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• Responsible for planning and preparing high quality medical writing deliverables and disclosure/transparency activities (e.g., study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, relevant modules of regulatory dossiers, Plain Language Summaries, Results Summaries for disclosure, briefing books).
• Develops medical writing and disclosure project timelines and reaches agreement with Head of Medical Writing and Disclosure and the relevant Study Execution Team/Clinical Development Team
• Coordinates and manages the tasks, roles, responsibilities and timing of the authoring team and internal / external reviewers to facilitate document completion
• Responsible for ensuring the appropriate plan, process and tools are in place for content editing, formatting, quality checking and publishing.
• Maintains awareness of potential delays, problems or gaps of information that exist in the team effort of document preparation in order to effectively manage the process.
• Coordinates the review, QC and assembly of medical writing deliverables and disclosure/transparency activities.
• Facilitates document finalisation, approval and electronic publishing.
• Ensure in-house / external resource available to provide medical writing deliverables as required by project team and in line with company objectives
• Participates in the development of Best Practices, SOPs work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
  
• Accountable for the creation and implementation of document templates and associated guidance tools (eg, formatting, style and program-specific guides), to allow teams to author quality documents that meet appropriate corporate, industry, regulatory (FDA, EMA) and international guidelines and requirements.
• Initiate new processes, standards and templates and updates in response to revised and new regulatory guidelines, through interactions with key stakeholders (eg, Shared Services).
• Identify global stakeholders (eg, CD, Regulatory, Project Management) to anticipate the requirement for new or updated medical writing processes.
  Create templates; lead cross-functional, global stakeholder review teams; facilitate issue resolution; obtain approval of templates.
• Proactively determine the needed changes to existing or creation of new guideline, standards, and templates.
• Provides input into the strategy for medical writing vendor selection, defines the scope of work to be outsourced and is responsible for medical writing vendor management.
• Forecast the resource needs for assigned projects and develop a strategy to meet those needs using internal resources and external vendors, as required.
• Develop and maintain specific medical writing vendor relationships where required.
• Participant in bid defense, contract development, work alignment and / or operation meetings.
• Negotiate with partner to determine roles, responsibilities, processes, and mutual expectations.
• Responsible for continuous improvement of in-house medical writing
• Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
• Develop expertise in Medical Writing skills, industry developments, tools and trends and share with the Medical Writing teams and other groups within the company as required.
• Provides expert medical writing support to other R&D and Seqirus groups where required.

Qualifications, Skills, and Experience:
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• An undergraduate degree in pharmacy, biological sciences or related disciplines is essential.
• Post-graduate qualifications desired (PhD or MD preferred)
• Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
• As a guide, a minimum of 7 years Clinical experience in the role of medical writer
• Excellent level of English language proficiency
• Expert MS Office skills with a special focus on word processing, tables and graphics, spreadsheet presentations and template

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
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About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX:
CSL).
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