Clinical Documentation Specialist responsible for receiving and processing healthcare documentation requests. Analyzing and validating requests while ensuring compliance with regulations and organizational standards.
About the role
- Medical Writer responsible for writing, editing, and maintaining Medical and Clinical documentation for Regulatory submissions. Essential for business growth and reputation with Health Authorities at Reckitt.
Responsibilities
- Manage the writing, editing and reviewing of diverse Regulatory and Clinical 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
Requirements
- Ability to develop appropriate research strategy and conduct a systematic review of available published data including retrieval, critical appraisal and appropriate citing of literature
- Bachelor’s degree preferably healthcare or life sciences (or equivalent) or PHD
- 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
- Experience of scientific writing and ability to adapt style and content for different target audiences
- Excellent attention to detail, technical editing and QC skills
- Skilled with MS Word and competent in MS Excel and the use of bibliography databases
- Experience of researching and scanning various internal and external databases and scientific literature
- Experience with Document Management systems
- Good awareness of the commercial drivers of the business and the OTC industry
Benefits
- 25 Days Annual Leave
- Pension
- Private Health
- Bonus
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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