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:-
- 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: -
- 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. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
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:-
- 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: -
- 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. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
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