Senior Medical Content Specialist
The Senior Medical Content Specialist is a key member of cross-functional clinical project teams.
This role is responsible for planning, preparing, managing and coordinating medical writing projects for Clinical Development within R&D.
* Responsible for planning and preparing high quality medical writing deliverables and disclosure/transparency activities.
* Develops medical writing and disclosure project timelines and reaches agreement with the 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.
Responsibilities include:
Coordinate the review, QC and assembly of medical writing deliverables and disclosure/transparency activities.
Facilitate 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.
Initiate new processes, standards and templates and updates in response to revised and new regulatory guidelines, through interactions with key stakeholders.
Identify global stakeholders 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
* 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.
* 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.
Benefits
CSL Seqirus offers its employees benefits such as opportunities for career growth and professional development.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world...