• Job Description

  Req#: 99741BR
  Cerner Enviza (an Oracle company) is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research.
  With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
  
  MISSON:
  • Compile, write, and edit medical writing deliverables covering all phrases of clinical research for submission to regulatory agencies.
  • Creation of documents, point of contact for clients, writes simple proposals and methodology sections of more complex proposals with input from Team Leader
  • Writing of study reports for non-interventional and clinical studies
  • Write scientific copies for a broader audience, including scientific liaisons, healthcare professional, and pharmaceutical representatives.
  • Creation of components of submission dossiers dossiers (modules of the Common Technical Document [CTD]), and safety reports (Periodic Benefit-Risk Evaluation Reports [PBRER] / Periodic Safety Update Reports [PSUR], Post Market Surveillance Reports [PMSRs] and Development Safety Update Reports [DSUR])
  • Supports Drug Safety Officer in creation of narrative safety reports and corresponding inquiries
  • Develops relationships with clients and is considered a point of contact by clients for project requests / questions
  • Writes simple proposals and methodology sections of more complex proposals with input from Team Leader Medical Writing or Directors
  • Prioritizes workload with minimal input from Team Leader Medical Writing to ensure agreed deadlines are met
  • Manages workload of their self and others to ensure that agreed deadlines are met
  • Develops own knowledge and personal skills in line with business requirements
  • Provides expertise to internal and external stakeholders to ensure all materials and publications comply with relevant SOPs, regulations and guidelines.
  • Demonstrates maturity in the assessment of own learning and development needs
  • Keeps abreast of developments in the pharmaceutical industry
  • Identifies and develops new ways of working to ensure continuous business improvement
  • Preparation of other project-specific documents such as observational plans and study protocols
  • Ensure all deliverables are in accordance with regulations, standards, and guidelines.
  • Conduct comprehensive literature searches to enhance background understanding and evaluate and analyze information covered in the writing.
  • Prepare abstracts, scientific exhibits, posters and verbal presentations.
  • Develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations.
  • Compile, write, and edit medical writing deliverables covering all phrases of clinical research for submission to regulatory agencies.
  • Creation of documents, point of contact for clients, writes simple proposals and methodology sections of more complex proposals with input from Team Leader
  • Writing of study reports for non-interventional and clinical studies
  • Write scientific copies for a broader audience, including scientific liaisons, healthcare professional, and pharmaceutical representatives.
  • Creation of components of submission dossiers dossiers (modules of the Common Technical Document [CTD]), and safety reports (Periodic Benefit-Risk Evaluation Reports [PBRER] / Periodic Safety Update Reports [PSUR], Post Market Surveillance Reports [PMSRs] and Development Safety Update Reports [DSUR])
  • Supports Drug Safety Officer in creation of narrative safety reports and corresponding inquiries
  • Develops relationships with clients and is considered a point of contact by clients for project requests / questions
  • Writes simple proposals and methodology sections of more complex proposals with input from Team Leader Medical Writing or Directors
  • Prioritizes workload with minimal input from Team Leader Medical Writing to ensure agreed deadlines are met
  • Manages workload of their self and others to ensure that agreed deadlines are met
  • Develops own knowledge and personal skills in line with business requirements
  • Provides expertise to internal and external stakeholders to ensure all materials and publications comply with relevant SOPs, regulations and guidelines.
  • Demonstrates maturity in the assessment of own learning and development needs
  • Keeps abreast of developments in the pharmaceutical industry
  • Identifies and develops new ways of working to ensure continuous business improvement
  • Preparation of other project-specific documents such as observational plans and study protocols
  • Ensure all deliverables are in accordance with regulations, standards, and guidelines.
  • Conduct comprehensive literature searches to enhance background understanding and evaluate and analyze information covered in the writing.
  • Prepare abstracts, scientific exhibits, posters and verbal presentations.
  • Develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations.
  • Master's Degree in a life science subject and several years practical experience in Medical Writing
  • Experience within CRO, pharmaceutical or life science organization
  • Ability to collaborate with others efficiently
  • Ability to manage several projects at any one time
  • Able to work to tight deadlines
  All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.
  
  

• About the company

  Cerner Corporation is an American supplier of health information technology services, devices, and hardware.

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