Principal Medical Writer Ii
vor 1 Monat
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 (e.g., 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 (e.g., Shared Services).Identify global stakeholders (e.g., 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 BenefitsCSL 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 SeqirusCSL 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 usAs 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
#J-18808-Ljbffr
-
Freelance Medical Content Writer
vor 2 Monaten
Melbourne, Österreich Hire Digital Ltd. VollzeitA leading pharmaceutical client is seeking aFreelance Medical Content Writerto create engaging articles and thought leadership pieces for their digital platform that provides data and personalized insights from various benchmarking surveys in the field of laboratory services and diagnostics. The ideal candidate will have a solid medical or pharmaceutical...
-
Freelance Medical Content Writer
vor 3 Monaten
Melbourne, Österreich Hire Digital Ltd. VollzeitA leading pharmaceutical client is seeking aFreelance Medical Content Writerto create engaging articles and thought leadership pieces for their digital platform that provides data and personalized insights from various benchmarking surveys in the field of laboratory services and diagnostics.The ideal candidate will have a solid medical or pharmaceutical...
-
Logistics Analyst Ii
vor 2 Monaten
Melbourne, Österreich Amentum VollzeitThis position is contingent upon contract award.Amentum is seeking a Logistics Analyst II to support an upcoming INSCOM G-4 Global Intelligence Logistics and Engineering (GILE) Support contract. These services will support tactical, operational, and strategic intelligence units, personnel, and their ground and aerial intelligence equipment and operations...
-
Melbourne, Österreich Tideri Jobbörse VollzeitA leading pharmaceutical client is seeking aFreelance Medical Content Writer to create engaging articles and thought leadership pieces for their digital platform that provides data and personalized insights from various benchmarking surveys in the field of laboratory services and diagnostics.The ideal candidate will have a solid medical or pharmaceutical...
-
2025 February Intake: Registrar – Medical
vor 21 Stunden
Melbourne, Österreich Charterhouse Medical VollzeitFull time, permanent position (12+ months), 86 hours a fortnight.Excellent salary & benefits.February and September 2025 availabilityRelocation AssistanceTraining HospitalCharterhouse Medical has partnered with Tasmania Health Service to support the General Medicine department.This position offers the chance to work as a Medical Practitioner at the primary...
-
Cra Ii
vor 21 Stunden
Melbourne, Österreich Icon Plc VollzeitCRA II/ Senior CRA - home-based in Sydney/ Melbourne/ Brisbane/ Adelaide.Join us and advance your career with an industry leading CRO.ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the...
-
2025 February Intake: Registrar – Medical
vor 12 Stunden
Melbourne, Österreich Charterhouse Medical VollzeitMedicine Save job 2025 February Intake: Registrar – Medical Job details Location: Melbourne Job Type: Permanent Discipline: Medicine Reference: 68173 Posted: about 1 month ago Date Range: Share this job Job description Full time, permanent position (12+ months), 86 hours a fortnight.Excellent salary & benefits.• February and September 2025...
-
Cra Ii
Vor 3 Tagen
Melbourne, Österreich Buscojobs VollzeitCRA II / Senior CRA - home-based in Sydney / Melbourne / Brisbane / Adelaide.Join us and advance your career with an industry leading CRO. ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to...
-
Assistant Principal-Range 1
vor 2 Monaten
Melbourne, Österreich State Government Of Victoria, Australia VollzeitJob type: Full time / From 28/01/2025Organisation: Schools (Government)Salary: Salary not specifiedOccupation: TeacherReference: 1454607Selection Criteria1. Educational leadership(i) Outstanding capacity for visionary and exemplary educational leadership of a school or college.(ii) Highly developed skills in leading and managing change including the...
-
Career Medical Officer, Cardiology
vor 3 Monaten
Melbourne, Österreich Sml Medical Supplies Inc VollzeitAbout Jessie McPherson Private HospitalJessie McPherson Private Hospital JMPH is a 115 bed tertiary level Private Hospital which has been co-located at Monash Medical Centre Clayton since 1987.d 31 North is a 26 bed Cardiology / Cardiothoracic surgical unit that will re-locate to the Victorian Heart Hospital VHH 2023, with increased capacity to 48 beds.co-...
-
Mi Systems Maintainer Integrator Ii
vor 2 Monaten
Melbourne, Österreich Amentum VollzeitThis position is contingent upon contract award Amentum is seeking a MI Systems Maintainer Integrator II to support an upcoming INSCOM G-4 Global Intelligence Logistics and Engineering (GILE) Support contract.These services will support tactical, operational, and strategic intelligence units, personnel, and their ground and aerial intelligence equipment and...
-
Mi Systems Maintainer Integrator Ii
vor 2 Monaten
Melbourne, Österreich Amentum VollzeitThis position is contingent upon contract awardAmentum is seeking a MI Systems Maintainer Integrator II to support an upcoming INSCOM G-4 Global Intelligence Logistics and Engineering (GILE) Support contract. These services will support tactical, operational, and strategic intelligence units, personnel, and their ground and aerial intelligence equipment and...
-
Ucat Question Writer
vor 2 Monaten
Melbourne, Österreich Contour Education VollzeitWe are thrilled to offer the exciting opportunity for a knowledgeable, insightful and enthusiastic individual to join us as a UCAT Question Writer at Contour MedPrep.This isn't just any content creation role. As Australia's fastest-growing and highest-scoring medical preparation program, our enrolments continue to triple annually, and thousands of aspiring...
-
Mi Systems Maintainer Integrator Ii
vor 2 Monaten
Melbourne, Österreich Tideri Jobbörse VollzeitThis position is contingent upon contract awardAmentum is seeking a MI Systems Maintainer Integrator II to support an upcoming INSCOM G-4 Global Intelligence Logistics and Engineering (GILE) Support contract.These services will support tactical, operational, and strategic intelligence units, personnel, and their ground and aerial intelligence equipment and...
-
Technical Writer
vor 3 Monaten
Melbourne, Österreich First Line Software, Inc VollzeitAt First Line Software we're creating a better world by finding innovative solutions to the problems people face every day.Where most see a setback, we see possibility.And we're looking for teammates who feel this way, too.We've established a network of over 500 teammates spread across the United States, Europe, Latin America, Australia, and India.As our...
-
Ucat Question Writer
vor 2 Monaten
Melbourne, Österreich Tideri Jobbörse VollzeitWe are thrilled to offer the exciting opportunity for a knowledgeable, insightful and enthusiastic individual to join us as a UCAT Question Writer at Contour MedPrep.This isn't just any content creation role.As Australia's fastest-growing and highest-scoring medical preparation program, our enrolments continue to triple annually, and thousands of aspiring...
-
Cra Ii
vor 2 Wochen
Melbourne, Österreich Syneos Health, Inc. VollzeitUpdated: December 24, 2024Location: Australia-Asia Pacific - AUS-Home-BasedJob ID:24007065Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development...
-
Deskside Technician Ii
vor 1 Woche
Melbourne, Österreich Stefanini, Inc VollzeitJob DetailsDeskside Technician IIDeskside Technician II Plaquemine, LA Posted: 11/14/2024Job ID#: 59018Job Category: Deskside Technician IIPosition Type: Full TimeDuration: PermWho we are Stefanini is a full service global provider of offshore, onshore and nearshore IT services, including application development and outsourcing services, IT infrastructure...
-
Document Writer
vor 12 Stunden
Melbourne, Österreich Buscojobs VollzeitJob detailsKey Selling Points 60.49Lifestyle Roster 5 / 4 Remote & Onsite workFlights can be arranged by clientAbout Our Client Our leading global mining and resource client is Australia's largest producer and supplier of seaborne metallurgical coal.With over 100 years of operation within Australia, they mine metallurgical coal across seven sites within...
-
Software Engineer Ii, Mobile
vor 1 Tag
Melbourne, Österreich Tbwa ChiatDay Inc VollzeitFlex is a growth-stage, NYC headquartered FinTech company that is creating the best rent payment experience.It's hard to believe that it's 2024 and paying rent on time is expensive, inflexible, and difficult.We're here to change that!Flex enables our users to pay rent throughout the month on a schedule that better fits their finances and budget.Our mission...
