Medical Writer
We are Reckitt
Research & Development
In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
The role of Medical Writer is integrated within Global Medical Affairs and reports directly to the Medical Writing Manager. This is a crucial role, requiring the successful applicant to take responsibility for writing, editing and maintaining high quality Medical and Clinical documentation for Regulatory submissions, which is essential for business growth and building a strong reputation with Health Authorities, as well as facilitating and supporting the on-going marketing of Reckitt medical devices, cosmetics and medicines. The Medical Writer will research, create and revise various documents associated with clinical research. Working closely alongside team members, the Medical Writer will ensure that all written documentation meets the strategic objectives and is produced to the highest possible scientific and editorial standards.
Your responsibilities
- Manage the writing, editing and reviewing of diverse Regulatory and Clinical Documents. These include but are not limited to: briefing documents, common technical document (CTD) clinical overviews and summaries, switch applications, integrated summaries of safety and efficacy, investigators’ brochures, clinical evaluation reports (CERs) and other Medical/Regulatory documents
- Provide input and edit/review of Regulatory and Clinical documents, as required, across all Reckitt product classifications, i.e. medical devices, cosmetics and medicines
- Manage the quality, accuracy and compliance with internal and external standards and the timely production of English language documents using electronic document management system
- Collaborate with subject matter experts across multiple departments to ensure quality and technical accuracy of documentation
- Develop, implement and manage templates for the standardisation of Regulatory and Clinical Documentation to support development and registration activities
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to guidelines/SOP’s including: distribution of drafts, chairing review meetings, incorporating revisions and completing sign off procedures
- Coordinate and collate high quality responses to Regulatory questions that arise during dossier/technical file review as required
- Review, improve and maintain existing documentation and create and maintain audit system/trails of all document changes and respond to Medical Information requests
The experience we're looking for
- Candidates with science degree. Bachelor minimum. Masters and Ph.D preffered
- Experience in preparing medical or scientific documents to a high standard is essential. Experience of
working in or for the Healthcare OTC industry, and/or direct experience of drafting documentation to
international Regulatory standards is desirable - Ability to develop appropriate research strategy and conduct a systematic review of available published data including retreival, critical apprisal and appropriate citing of literature
- Experience of scientific writing and ability to adapt style and content for different audiences
The skills for success
Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes.
What we offer
Equality
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Medical Device, Medical Research, Clinical Research, Counseling, Nutrition, Healthcare