We have an exciting opportunity for a Medical Writer within our R&D Division. Reporting to the Head Medical Writing & Disclosures. The 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 (CD). He/she 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
Your main accountabilities will include, but not limited to:
Responsible for planning and preparing high quality medical writing deliverables (e.g. study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, relevant modules of regulatory dossiers, risk management plans, pharmacovigilance ad hoc and periodic reports, briefing books), presentations (e.g., abstracts, posters, Advisory Committees, Advisory Boards) and manuscripts that support the clinical development and regulatory requirements for CD.
- Developing medical writing project timelines
- 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.
- Maintaining 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.
- Coordinating the review, QC and assembly of medical writing deliverables.
- Facilitating document finalisation, approval and electronic publishing.
- Ensuring 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 medical-writing related Best Practices, SOPs work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
- Responsible for the creation and implementation of document templates and associated guidance tools (e.g. formatting, style and program-specific guides), to allow teams to author quality documents that meet appropriate corporate, industry, regulatory (FDA, EMEA) and international (GPP) guidelines and requirements.
- Garner input from global stakeholders (eg, CD, Regulatory, Project Management). Creating templates; lead cross-functional, global stakeholder review teams; facilitate issue resolution; obtain approval of templates.
- Facilitating implementation, adherence to and maintenance of guidelines, standards and templates through interactions with key stakeholders (e.g. Shared Services).
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;
- Developing and maintain specific medical writing vendor relationships where required.
- Participant in bid defense, contract development, work alignment and / or operation meetings.
Responsible for continues improvement of in-house medical writing
- Cultivating an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks
To be successful in this role, the jobholder will have:
- An undergraduate degree in pharmacy, biological sciences or related disciplines which is essential
- Plus a Post-graduate qualification such as (PhD or MD) is preferred
- Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
- A minimum of 4 years Clinical experience in the role of medical writer
- Excellent level of English language proficiency and strong communication skills to deal with senior managers across the business
- Expert MS Office skills with a special focus on word processing , tables and graphics, spreadsheet presentations and template
- Excellent organisational and time management skills
- An excellent understanding of all aspects of ICH GCP, SOPs, and international publication planning guidelines
- Successful track record of leading complex clinical / regulatory writing projects
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